Openlane, EU Jobs in Usa

• Make good money in an exciting field
• Be your own boss and set your own hours
• Flexible work environment
• Ability to work with minimal guidance and supervision

• Make good money in an exciting field
• Be your own boss and set your own hours
• Flexible work environment
• Ability to work with minimal guidance and supervision

Role Overview

The Director, E-Commerce & Amazon Marketplace owns revenue, merchandising performance, and demand execution across TYR’s DTC (Shopify Plus) and Amazon Marketplace businesses globally, including responsibility for TYR’s EU digital commerce sites.

This is a senior operating role accountable for translating product, category, and brand strategy into measurable commercial results across owned and marketplace channels in the U.S. and Europe. The role blends category-led merchandising, Amazon P&L ownership, international e-commerce leadership, lifecycle demand execution, and platform-level technical fluency, with a strong mandate to leverage Shopify Plus, Amazon Vendor/Seller Central, advanced attribution, CRM, and AI-enabled technologies to drive scale, efficiency, and profitability across regions.

Core Operating Framework

Merchandising is the Engine: Product accuracy, hierarchy, availability, and lifecycle discipline drive conversion, AOV, sell-through, and margin across regions.

Demand Execution is the Accelerator: Attribution clarity, lifecycle orchestration, and execution rigor scale revenue efficiently across markets.

Technology is the Multiplier: Platform leverage, automation, clean data, and AI-driven insight accelerate speed, precision, and learning globally.

People are the Force Multiplier: Clear ownership, execution rigor, and cross-functional alignment determine outcomes across regions and teams.

Key Responsibilities

1. Commercial Ownership & Revenue Leadership

• Own top-line revenue and contribution margin across TYR DTC (Shopify Plus), Amazon Marketplace, and EU digital commerce sites.
• Set and manage monthly, quarterly, and annual revenue plans by region and channel, including pacing, promotional impact, FX considerations, and inventory constraints.
• Drive sustained improvement across CR, AOV, UPT, RPV, full-price sell-through, and gross margin across U.S. and EU markets.
• Partner with Finance on forecasting, scenario planning, and inventory exposure by category, channel, and region.

2. Merchandising as the Engine (Director-Level Scope)

• Define, own, and continuously evolve TYR’s digital merchandising strategy across all core categories, channels, and regions.
• Own Shopify Plus theme architecture and merchandising execution for both U.S. and EU sites, including homepage systems, PLP/PDP layouts, launch frameworks, and reusable modules.
• Demonstrate deep hands-on knowledge of Shopify merchandising tools: metaobjects, metafields, automated collections, tagging, rules-based merchandising, and manual overrides.
• Own taxonomy, category architecture, product hierarchy, hero logic, and visual priority across DTC (U.S. & EU) and Amazon.
• Ensure regional relevance in merchandising while maintaining global brand and category consistency.
• Lead seasonal drops, capsules, and launches with clear entry points, storytelling hierarchy, and conversion paths adapted by region.
• Own performance of homepage, PLP, PDP, campaign landers, and Amazon detail pages (titles, bullets, imagery, A+ content, Brand Store).
• Operate a rigorous merchandising performance scorecard including CR, AOV, newness vs carryover, size-level availability, markdown cadence, recovery, and GMROI by region.
• Enforce lifecycle discipline from launch → scale → sustain → exit, dynamically adjusting placement, storytelling, and promotional pressure by market.

3. Amazon Marketplace Leadership (Global)

• Own Amazon Marketplace strategy, execution, and P&L across North America and Europe.
• Accountable for Amazon revenue, contribution margin, catalog health, pricing, promotions, and Buy Box performance by marketplace.
• Lead Amazon merchandising excellence including PDP optimization, search discoverability, ratings and reviews, and Brand Store execution.
• Oversee Amazon advertising (Sponsored Products, Sponsored Brands, DSP where applicable) with strict incrementality and margin discipline.
• Partner with Operations and Supply Chain on forecasting, inbound flow, availability, and region-specific inventory risk.

4. Demand, CRM & Attribution Ownership

• Own lifecycle demand execution across paid performance channels, CRM (email, SMS, personalization), and onsite campaign execution for U.S. and EU sites.
• Ensure attribution clarity using Northbeam as the primary multi-touch attribution platform across regions.
• Own Klaviyo strategy across segmentation, automation, lifecycle journeys, and revenue contribution globally.
• Translate attribution insights into regional budget allocation, channel prioritization, and onsite optimization.

5. Platform Leadership: Shopify Plus, Amazon & CRM

• Own platform strategy across Shopify Plus (U.S. & EU) and Amazon, ensuring scalability, localization readiness, execution speed, and data integrity.
• Oversee regional site requirements including language, currency, tax, duty, and compliance considerations in partnership with Finance and Operations.
• Partner with Technology and agencies to prioritize enhancements, reduce technical debt, and enable advanced merchandising and personalization globally.
• Ensure CRM is fully integrated with merchandising, lifecycle execution, and commercial priorities across regions.

6. Emerging Technology & AI Enablement

• Maintain strong awareness of emerging technologies including AI-driven personalization, merchandising optimization, and predictive analytics with applicability across regions.
• Evaluate and operationalize tools that improve conversion, efficiency, and speed-to-insight globally.
• Ensure technology adoption is commercially justified, measurable, and scalable across markets.

7. Inventory, Planning & Lifecycle Alignment

• Partner with Planning & Allocation to align buy depth, flow, and replenishment to digital demand signals across U.S. and EU markets.
• Manage in-season risk through merchandising prioritization, promotional levers, and assortment optimization by region.
• Drive disciplined markdown strategies that protect margin while clearing exposure, accounting for regional seasonality and market dynamics.
• Monitor inventory productivity through turns, weeks of supply, and GMROI by region.

8. Team Leadership & Operating Rhythm

• Lead E-Commerce, Merchandising, CRM, and Amazon teams with clear roles, KPIs, and accountability across regions.
• Establish weekly, monthly, and quarterly operating cadences including regional scorecards, launch readiness, and post-mortems.
• Serve as the primary cross-functional partner to Product, Creative, Operations, Technology, Finance, and EU stakeholders.
• Hold teams accountable for execution accuracy, timelines, and results globally.

Key Metrics of Success

• Revenue vs Plan by channel and region (U.S. & EU)
• Conversion Rate (CR) & Revenue per Visitor (RPV) by market
• Average Order Value (AOV) & Units per Transaction (UPT)
• Amazon Contribution Margin & Advertising Efficiency by marketplace
• Full-Price Sell-Through & Gross Margin
• Inventory Turns, GMROI, and Markdown Efficiency by region
• CRM Revenue Contribution & Retention Rate
• Speed-to-Insight & Execution Accuracy

Qualifications

• 7–10+ years of progressive leadership experience in DTC e-commerce and Amazon Marketplace management, including international markets.
• Demonstrated experience owning and scaling EU or international Shopify sites.
• Deep, hands-on experience with Shopify Plus and Amazon Vendor/Seller Central.
• Proven ownership of Northbeam attribution and Klaviyo CRM with demonstrated revenue impact.
• Experience scaling Amazon as a meaningful revenue and profit channel without eroding brand or DTC economics.
• Strong financial acumen with comfort operating close to the P&L, including regional forecasting and FX considerations.
• Experience leading cross-functional and geographically distributed teams.

Ideal Leadership Profile

This role is for a commercially obsessed, analytically rigorous, and technologically fluent global operator who understands that Amazon, DTC, international execution, data, and AI-driven insight are inseparable growth engines. They balance global brand consistency with local market execution, lead teams with clarity and urgency, and continuously evolve the business through tools and processes that deliver measurable growth, efficiency, and scale.

• Lead and implement the company’s HSE strategy across renewable energy projects in Ireland and Europe
• Ensure compliance with Irish and European health and safety legislation including Construction Regulations, PUWER, LOLER and associated directives
• Manage and maintain HSE management systems including ISO 45001 and ISO 14001 across all project locations
• Carry out internal and external HSE audits and ensure corrective actions are implemented effectively
• Provide guidance to project teams on RAMS, risk assessments, permit to work systems and safe work planning
• Drive a positive safety culture across project teams and subcontractors with a focus on behavioural safety
• Develop and maintain HSE performance reporting and KPIs across multiple European projects
• Lead incident investigations, root cause analysis and continuous improvement initiatives
• Deliver training and mentoring for site managers, engineers and supervisors on key safety topics
• Liaise with regulatory authorities, certification bodies and project stakeholders during inspections and audits
• Support environmental and sustainability initiatives including waste management and environmental risk controls
• Produce monthly and quarterly safety performance reports for senior management and project stakeholders

• Chartered IOSH member CMIOSH or equivalent qualification such as NEBOSH Diploma or MSc in Occupational Health and Safety
• 8 to 10 years experience in health and safety within construction, utilities, power generation or renewable energy projects
• Strong background working on wind farms, solar farms, battery storage or grid infrastructure projects is highly desirable
• Experience managing health and safety across multiple sites and jurisdictions within the EU
• Proven experience implementing and managing ISO 45001 safety management systems
• Excellent knowledge of Irish and European health and safety legislation and compliance requirements
• Strong leadership and communication skills with the ability to influence teams at all levels
• Experience leading audits, incident investigations and safety improvement programmes
• Comfortable working across multiple sites with regular travel across Ireland and Europe
• Practical, solutions focused approach to risk management and safety leadership

Senior Manager, Ecommerce

Lead global eCommerce business planning, P&L management, and international expansion across DTC sites and Amazon marketplaces. This role is the central connector between strategy, finance, operations, marketing, and regional teams to deliver disciplined, data-driven growth.

Key Responsibilities

• Own annual and quarterly planning (budgets, targets, forecasts) for global eCommerce.
• Manage topline, margin, and investment planning across DTC and Amazon (US, EU, AU, IN, etc.).
• Own global eCommerce P&L tracking, reviews, and performance insights.
• Identify risks and opportunities by region, channel, and marketplace.
• Drive global Amazon marketplace expansion and support market entry (assortment, pricing, costs, advertising, compliance).
• Align cross-functional partners (Marketing, Supply Chain, Operations, IT, Finance) and lead regular business reviews.
• Establish scalable planning, reporting, and governance processes to ensure execution against goals.

Qualifications

• 8+ years in eCommerce, business planning, or commercial strategy.
• Hands-on experience with Amazon (1P preferred) and DTC business models.
• Proven P&L ownership or management experience.
• Experience with international eCommerce expansion.
• Strong analytical, financial, and communication skills; effective cross-functional leader.

Preferred

• Background in beauty, CPG, or consumer brands.
• Experience with Amazon international marketplaces (EU, AU, IN).
• Advanced Excel / financial modeling; BI tools a plus.

ABOUT THE ROLE:

Skechers is enabling our business with AI through the development and adoption of private, proprietary AI technologies. The Senior Technical Solutions Analyst - GenAI is a key role within the Software Engineering and Architecture organization and will be central to continually developing and improving our Generative AI platform and technologies within Skechers.

The Senior Technical Solutions Analyst - GenAI will be at the helm of managing Skechers’ private GenAI platform, SkechAI, which features two privately instanced Generative AI models, Claude & Stable Diffusion, along with several business-focused GenAI use cases. This pivotal role involves steering the platform to maximize its value to Skechers by overseeing the entire lifecycle of GenAI use case development from ideation to delivery and beyond. The GenAI Technical Analyst & Functional Lead will be the visionary force, identifying and prioritizing GenAI use cases and product enhancements, ensuring strategic alignment and effective deployment of resources. They will be the lead-from-the-front technology and Agile delivery experts deeply dedicated to their projects

This role will collaborate and work within high-velocity software engineering teams, bringing expertise in Agile software delivery. The candidate should be an experienced and motivated technologist who possesses a unique balance of technical depth and strong interpersonal skills. Should have excellent design, lead skills showing commitment, end to end vision, planning, integrity, and pragmatic approach to drive the organization towards continual success.

WHAT YOU'LL DO:

• Lead business user workshops to identify, collect user feedback and potential GenAI use cases.
• Lead collection and prioritization of GenAI use cases, product enhancements, ensuring alignment with Skechers’ strategic goals.
• Serve as the primary liaison between business units, enabling functions, the AI Innovation Council, and the product team to foster collaboration and ensure the platform’s success.
• Advise the software engineering team on the development of use cases and product features based on a comprehensive understanding of Skechers' business needs.
• Stay abreast of leading practices in GenAI product development and integrate these into Skechers’ strategy to remain competitive and innovative.
• Ensure compliance with GDPR, the EU AI Act, and other relevant data privacy and security regulations by working closely with legal and compliance teams.
• Establish and monitor OKRs and KPIs to manage and measure the value of the GenAI platform, adapting strategies as necessary to meet business objectives.
• Represent the Software Engineering & Architecture group in end-to-end solution conversations with customers and stakeholders.
• Demonstrate leadership skills in driving and owning solutions.
• Participate in knowledge sharing and guidance to team members to help grow gen AI skills and capabilities.
• Engage, collaborate, and partner with Skecher’s Digital, Retail, Wholesale, Customer Service, Supply Chain leaders and partners across Business and Technology to drive long and short-term business value through AI solutions.
• Actively contributes to a culture of high performance, innovation, and continuous improvement.
• Build trust and confidence with Gen AI solutions to various business stakeholders assuring expected tech outcomes and desired results.

WHAT YOU'LL DO:

• Lead business user workshops to identify, collect user feedback and potential GenAI use cases.
• Lead collection and prioritization of GenAI use cases, product enhancements, ensuring alignment with Skechers’ strategic goals.
• Serve as the primary liaison between business units, enabling functions, the AI Innovation Council, and the product team to foster collaboration and ensure the platform’s success.
• Advise the software engineering team on the development of use cases and product features based on a comprehensive understanding of Skechers' business needs.
• Stay abreast of leading practices in GenAI product development and integrate these into Skechers’ strategy to remain competitive and innovative.
• Ensure compliance with GDPR, the EU AI Act, and other relevant data privacy and security regulations by working closely with legal and compliance teams.
• Establish and monitor OKRs and KPIs to manage and measure the value of the GenAI platform, adapting strategies as necessary to meet business objectives.
• Represent the Software Engineering & Architecture group in end-to-end solution conversations with customers and stakeholders.
• Demonstrate leadership skills in driving and owning solutions.
• Participate in knowledge sharing and guidance to team members to help grow gen AI skills and capabilities.
• Engage, collaborate, and partner with Skecher’s Digital, Retail, Wholesale, Customer Service, Supply Chain leaders and partners across Business and Technology to drive long and short-term business value through AI solutions.
• Actively contributes to a culture of high performance, innovation, and continuous improvement.
• Build trust and confidence with Gen AI solutions to various business stakeholders assuring expected tech outcomes and desired results.

REQUIREMENTS:

• Bachelor’s or Master’s degree in Computer Science, Business, or a related field.
• 5+ years of experience in product management or business analysis, preferably with experience in Generative AI, Artificial Intelligence, or related products.
• Experience working in a hybrid IT environment that includes a mix of traditional and modern technology stacks.
• Ability to communicate complex topics with precision and clarity.
• Ability to accurately categorize and effectively communicate requirements.
• Experience working directly with business-facing groups outside of development is a plus.
• Experience working within an Agile team is a plus.
• Extensive experience documenting development requirements, process flows, and testing requirements, as well as coordinating code reviews and documentation sign-offs.
• Ability to create strong presentations and roadmaps, and collaborate effectively with senior technology leaders.
• Strong communication skills and ability to work effectively as a team player.

The pay range for this position is $150,000-$185,000/yr USD.

About Skechers

Skechers, a global Fortune 500® company, develops and markets a diverse range of lifestyle and performance footwear, apparel, and accessories. Serving over 180 countries and territories, Skechers connects customers to products through department and specialty stores, e-commerce and digital stores, and through our more than 5,300 Skechers retail locations.

Equal Employment Opportunity

Skechers is committed to providing a safe, inclusive, and respectful work environment. Skechers provides equal employment opportunities for all employees and applicants for employment without regard race, color, religion, gender, gender identification and expression, national origin, marital status, age, disability, genetic information, military status, sexual orientation, or any other protected characteristic established by local, state or federal law.

Reasonable Accommodation

Applicants for employment who require a reasonable accommodation to apply for a job should request appropriate accommodation by emailing

To perform this job successfully, an individual must be able to perform each job responsibility satisfactorily. The skills, abilities and physical demands described are representative of those duties that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities, who are otherwise qualified for the job position, to perform the essential functions.

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

The Quality Engineer I Quality Operations specializes in Quality Operations, and is responsible for overseeing and improving the quality of manufacturing processes, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives to enhance product quality and customer satisfaction. You will play a key role in ensuring that our manufacturing operations meet the highest standards of quality and efficiency while adhering to relevant regulations and industry best practices.

Job Responsibilities and Essential Duties

• 
  
• Develop, implement, and maintain quality control processes and procedures for manufacturing operations to ensure compliance with regulatory requirements and industry standards.
  
• Establish and monitor key performance indicators (KPIs) to assess manufacturing quality and identify opportunities for improvement.
  
• Participate/ Lead validation and verification activities for manufacturing processes, equipment, and software systems to ensure they meet quality and regulatory requirements.
  
• Develop/ review validation protocols, execute validation studies, and analyze data to ensure process robustness and reliability.
  
• Ensures through Design Transfer activities the Device Master Records (DMRs) contents are developed, controlled, and maintained leading to Risk based Manufacturing Control Plans.
  
• Support/ Investigate and resolve Out of Tolerance events identified during equipment/ instrument calibrations.
  
• Investigate product nonconformances, conduct root cause analysis, and implement corrective and preventive actions (CAPA).
  
• Track and monitor CAPA effectiveness to ensure issues are resolved and prevented.
  
• Support the Health and Hazard Evaluation process by gathering required data and performing in-depth analysis prior to sharing the information with the Field Action Committee.
  
• Implement corrective and preventive actions (CAPAs) to address root causes and prevent recurrence of quality issues.
  
• Facilitate risk management activities related to manufacturing processes, identifying, and mitigating risks to product quality, safety, and efficacy.
  
• Implement risk-based decision-making processes to prioritize quality activities and allocate resources effectively.
  
• Lead and support continuous improvement projects aimed at enhancing manufacturing processes, reducing defects, and optimizing productivity.
  
• Utilize quality tools and methodologies, such as Six Sigma, Lean Manufacturing, and Statistical Process Control (SPC), to drive process optimization and waste reduction.
  
• Ensure compliance with applicable regulations, including FDA Quality System Regulation (QSR), ISO 13485, and other international standards.
  
• Support both internal and external audits as an SME for Production & Process Controls and presents records of activities related to Design Transfer for New Product Development and Design Changes.
  

Minimum Requirements

• 
  
• Bachelor's degree in engineering, Science, or other related field is required.
  
• Six Sigma Green Belt or other applicable certifications are a plus.
  
• Minimum 1 year experience in Quality or Engineering.
  
• Experience in a medical device or pharmaceutical industry.
  
• Experience with Class III disposable and/or Electro-Mechanical medical devices is preferred.
  
• Knowledge and understanding of the US Food and Drug Administration (FDA) 21 CFR 820, ISO 13485, ISO 14971, EU MDD, and EU MDR. Knowledgeable on specific requirements for Design Controls and Risk Management is preferred.
  
• Knowledge of application & selection of Sampling Plans, to support Risk based Manufacturing Controls Plans.
  
• Project management and leadership experience is desirable.
  
• Knowledge of Microsoft Office Products such as Word, Excel, or equivalent software applications.
  

Required Knowledge, Skills and Abilities

• 
  
• Strong analytical and problem-solving skills.
  
• Excellent communication and interpersonal skills.
  
• Proficiency in quality tools and methodologies (e.g., Six Sigma, FMEA, Gage R&R).
  
• Ability to work effectively in a cross-functional team environment.
  
• Ability to review and understand technical standards and their requirements for products.
  
• Lead improvement initiatives, either independently or as part of cross-functional teams
  

The base salary for this the position is a minimum salary of $87,000 and a maximum of $90,000 with 8% annual bonus

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

Notice: MCRA’s Talent Solutions division works to unite top talent with opportunities on our clients’ teams. This posting is not for a position directly at MCRA, but rather for a position with a MCRA client that our team is helping to recruit and fill.

MCRA's client, a commercial-stage medical device company specializing in designing, developing, and marketing orthopedic fracture repair and stabilization products, is in search of a Director of Quality and Regulatory Affairs to provide support across Regulatory, Quality Assurance, Operations, and Research & Development (R&D).

Primary Roles:

• Is a key member of the senior leadership, and is responsible for the successful operation of the company's quality and regulatory systems. Essential functions include the development, implementation, maintenance, and improvement of company-wide quality and regulatory systems, integrating continuous improvement activities.
• Serves as our clients Management Representative under ISO and FDA requirements, and takes the lead role in ensuring that the quality management system is efficient, effectively implemented and ensures compliance with the requirements of applicable regulatory agencies. Responsible for the generation and maintenance of our client's Quality systems, with direct oversight for the processes for Complaints Management, CAPA, Risk Management, Post-Market Surveillance, and Regulatory Reporting.
• Is responsible for leading the resolution of quality and compliance issues within the business and provide routine quality feedback and leadership to cross-functional groups
• Serves as the official correspondent to Competent Authorities (e.g. FDA, EU countries, etc) as well as Notified Body. Responsible for maintaining compliance registrations and device listings.
• Ensuring compliance with FDA and other applicable international regulations and requirements for the design, development, distribution, and maintenance of medical devices and provide general regulatory support to the organization

Responsibilities:

Quality Systems

• Provide operational leadership in planning and management of quality system activities to maintain appropriate QMS certification
• Responsible for leading and interfacing with any Notified Bodies or Competent Authorities during inquiries or facility inspections by such organizations
• Acts as lead in all product complaint and recall campaigns.
• Responsible for interfacing with and following up with any Customers regarding complaints
• Responsible for Supplier Quality assurance program
• Responsible for Measurement, analysis and improvement programs, including quality trending, CAPA system, and the Internal Quality Audit program for our client.
• Leads the Management Review process

Quality Engineering

• Ensures all inspection and quality plans are statistically sound and can ensure quality levels that exceed requirements
• Ensures all device history records are complete and reviewed prior to release of product
• Assist suppliers by providing information to enable process improvements
• Ensure all manufactured products are conforming to FDA Quality System, ISO 13485, MDD, and MDR
• Supports the engineering staff with PPQA activities, validations, and statistical analysis of new products and processes
• Leads Risk Management and Post-Market Surveillance activities

Regulatory Affairs

• Develop and implement global regulatory and compliance strategies to:
• Ensure all products designed, manufactured and/or shipped meet all regulatory, corporate and customer requirements for quality, safety and efficacy;
• Ensure proper and timely preparation and maintenance of national and international new product submissions, registration/licensing renewals, product listings, post market surveillance reports, import and export documents, safety testing, and other national and international requirement
• Optimize and focus on quality during the design and change control processes for both new and existing products;
• Ensure all advertising and promotion materials conform to applicable FDA, EU, and, where applicable, other country regulations.
• Responsible for the CE Mark approval process for all products, and Technical File generation and maintenance
• Responsible for writing Letters to File as required
• Participates in the development and writing of 510(k) submissions with the management team utilizing external resources as required
• Responsible for external agency reporting

Education:

• Bachelor’s Degree in Engineering or Natural Science preferred, coupled with approximately 10 years of combined experience in QA / RA in the medical devices industry; experience regarding medical device design, development and manufacturing regulations, especially 21 CFR Part 820 Quality System Regulation, the MDD and MDR Directives, as well as ISO 13485 requirements. 5 years of experience managing supervisory personnel and contributing toward the development of department strategies.

Experience/ Skills:

• Ability to build efficient quality assurance systems; including electronic document and record control, CAPA, NCR, complaint, training, metrics
• Demonstrated ability to write, review, execute and critique validation protocols, investigation plans, root cause analyses, NCRs, CAPAs, complaints, trend report
• Has experience with applying ISO 14971 principles to medical devices throughout all stages of the product's lifecycle.
• Demonstrated leadership skills and team building skills, inspires others toward continuous quality improvement
• Able to solve complex quality, technical, managerial or budgeting problems
• Readily adapts to changing priorities, effectively manages own time and direct reports to ensure tasks, projects are completed on time to meet growth objectives. Adjusts easily and readily to a fast-paced work environment
• Working knowledge of data acquisition, analysis and statistical software
• Demonstrated ability to manage multiple projects and technical personnel simultaneously
• Successful oral and written communication skills, business acumen and assertive decision-making ability
• Excellent computer skills, including MS Office proficiency

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.

MCRA, LLC is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

General Description:

Supervises staff and executes QC Biochemistry laboratory activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations, applicable International Regulations, processes and procedures. Establishes and implements QC Biochemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day to day operations of the Biochemistry laboratory.

Essential Functions of the job:

• Lead the QC Biochemistry GMP laboratory through late phase activities.
• Oversee QC Biochemistry laboratory related quality systems to ensure conformance with regulations and quality standards.
• Supervise a highly efficient QC Biochemistry team. Identify and develop key talents.
• Manage QC Biochemistry laboratory routine operations, including but not limited to validation, SOP revisions, specification updates, testing records, personnel training and, scheduling, etc.
• Execute laboratory bench work for analytical methods such as Potency assays, Binding ELISA, Cell Culture, Residual Host Cell Protein(HCP), Residual DNA as required.
• Ensure Biochemistry laboratory compliance with Environmental Health and Safety (EHS) standards.
• Ensure timely completion of testing (e.g., in-process, DS release, DP release, and stability testing) to ensure timely generation and reporting of test results In support of manufacturing operations.
• Ensure appropriate investigation of OOS events, discrepancies, lab errors, and equipment failures.
• Implementation of effective corrective actions and preventive actions (CAPAs).
• Participate in internal and external GMP audits where possible.
• Manage QC Biochemistry method transfers and method validation activities, including transfer/validation strategy and approval of protocols and reports.
• Ensure that the QC Biochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives.
• Manage, motivate, coach and mentor direct reports.
• Undertake any other duties as required.

Core Competencies, Knowledge, and Skill Requirements:

• Scientific degree (ideally in Biochemistry, molecular biology, biotechnology or related).
• Minimum of 5-7 years working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required.
• Working knowledge and experience with Biochemistry analytical methods such as Potency assays, Binding ELISA, Cell Culture, Residual Host Cell Protein(HCP), Residual DNA as well as instruments such Incubators, Biosafety Cabinets, Plate Washers, and Microplate Readers, etc.
• Knowledgeable with USP/EP and cGMP/EU GMP regulations.
• Direct experience in a GMP quality control lab is a must.
• Familiar with instrument and equipment validation.
• Expert knowledge of quality control principles, practices, and standards for the biopharmaceutical industry.
• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
• Credible and confident communicator (written and verbal) at all levels.
• Strong analytical and problem-solving ability.
• Excellent project management skills.
• Hands-on approach, with a ‘can do’ attitude.
• Ability to prioritize, demonstrating good time management skills.
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Self-motivated, with the ability to work proactively using own initiative.
• Committed to learning and development.

Supervisory Responsibilities:

• Supervise a highly efficient QC Biochemistry team. Identify and develop key talents.
• Manage QC Biochemistry laboratory routine operations, including but not limited to validation, SOP revisions, specification updates, testing records, personnel training and scheduling, etc.
• Manage QC Biochemistry method transfers and method validation activities, including transfer/validation strategy and approval of protocols and reports.
• Ensure that the QC Biochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives.
• Manage, motivate, coach and mentor direct reports.

Essential Functions of the job:

• Review and validate QC data and test records.
• Support investigations related to Out of Specification (OOS), Out of Trend (OOT), and Out of Expectation (OOE) results.
• Ensure compliance with current Good Manufacturing Practices (cGMP) in the laboratory.
• Assist in the technical documentation of investigations and change control assessments to evaluate the impact on product quality, in alignment with FDA/EU regulations, international standards
• Undertake other duties as required.

This position is ideal for candidates who are detail-oriented and committed to quality assurance in the pharmaceutical industry.

Education/Experience Required:

• Bachelor’s Degree or above in Chemistry, Biochemistry, or Biotechnology related scientific discipline. Scientific degree (ideally chemistry, biochemistry, biotechnology or related).
• Minimum 4 years working experience in an FDA-regulated biotechnology or pharmaceutical company is required.
• Working knowledge and experience with chemistry analytical methods such as HPLC, GC, TOC, Capillary Electrophoresis (CGE-Reduced, CGE-Non-Reduced, and Capillary Zone Electrophoresis), etc.
• Strong working knowledge with USP/EP and cGMP/EU GMP.
• Technical writing experience.
• Familiar with instrument and equipment validation.
• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
• Credible and confident communicator (written and verbal) at all levels.
• Strong analytical and problem-solving ability.
• Hands-on approach, with a ‘can do’ attitude.
• Ability to prioritize, demonstrating good time management skills.
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Self-motivated, with the ability to work proactively using own initiative.
• Committed to learning and development
• Self-motivated, with the ability to work proactively using own initiative.

Computer Skills:

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

Travel:

• Must be willing to travel approximately 10%.
• Ability to work on a computer for extended periods of time.

Job Title: Senior Analyst, QC Chemistry

Work Location: Mercer County, New Jersey

Summary:

Perform QC Chemistry laboratory activities with a primary focus on capillary electrophoresis techniques to support GMP manufacturing, testing, and release of material, intermediates and finished biological products (monoclonal antibodies) under FDA/EU regulations, applicable International Regulations, and internal processes and procedures.

Responsibilities:

• Perform routine and non-routine testing using capillary electrophoresis techniques (e.g., CE-SDS, CZE, icIEF) in the QC Chemistry laboratory to ensure timely and compliant generation and reporting of in-process, release, and stability test results in support of manufacturing operations.
• Review, interpret, and report analytical data in accordance with GMP regulations and internal procedures.
• Lead troubleshooting efforts for analytical methods and instrumentation related to CE.
• Conduct laboratory investigations, including OOS, Out of Trend, deviations, and invalid assays.
• Implement corrective actions and preventive actions (CAPAs).
• Participate in transfer and method validation activities, including protocol preparation, protocol execution, and report preparation.
• Support routine operations, including but not limited to instrument qualification and maintenance, SOP generation and revision, test record keeping, etc.
• Maintain equipment in a qualified and calibrated state, coordinating with metrology or vendors as needed.
• Manage inventory of reagents and supplies for the laboratory.
• Participate in internal and external GMP audits, as needed.
• Train other junior level analysts and new hires on CE instrumentation, GMP practices, and data analysis.
• Serving as subject matter expert in one or more areas of required testing.
• Undertake other duties as required.

Qualifications:

• Bachelor’s or above in Chemistry, Biochemistry, or Biotechnology related scientific discipline.
• Minimum of 4+ years of working experience in an FDA-regulated biotechnology or pharmaceutical company.
• CE experience is an absolute must have.
• Familiar with Waters Empower Chromatography Data System.
• Familiar with instrument and equipment validation.
• Working knowledge with USP/EP and cGMP/EU GMP regulations.
• Working knowledge and experience with chemistry analytical methods such as HPLC, GC, TOC, Capillary Electrophoresis (CGE-Reduced, CGE-Non-Reduced, and Capillary Zone Electrophoresis), etc.
• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
• Credible and confident communicator (written and verbal) at all levels.
• Strong analytical and problem-solving ability.
• Hands-on approach, with a ‘can do’ attitude.
• Ability to prioritize, demonstrating good time management skills.
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Self-motivated, with the ability to work proactively using own initiative.
• Committed to learning and development.
• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
• Must be willing to travel approximately 10%.
• Ability to work on a computer for extended periods of time.

Kelly® Science & Clinical is seeking a Document Control & Training Manager for a Direct Hire position at a leading specialty pharmaceutical company in Sacramento, CA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Salary:

$80-90k

Overview:

In this role, you will lead and mentor teams to manage document control and GMP training programs, ensuring regulatory compliance and inspection readiness, driving digital transformation, supporting cross-functional collaboration, and fostering a culture of continuous improvement and operational excellence within a fast-growing pharmaceutical and biotech organization.

Schedule:

Monday-Friday, standard working hours

Responsibilities:

• Lead and Develop Teams: Direct, mentor, and inspire the Document Control and GMP Training teams, fostering growth, accountability, and continuous improvement.
• Set Strategic Direction: Establish KPIs, objectives, and overall strategy for document control and training in alignment with organizational quality goals.
• Champion Regulatory Compliance: Ensure robust document management and training programs meet global regulatory requirements (21 CFR 210/211, EU GMP) and maintain inspection readiness.
• Oversee Document Lifecycle: Supervise the creation, organization, revision, archival, and retrieval of critical documents such as SOPs, Master Batch Records, and logbooks for multi-product/multi-site operations.
• Manage GMP Training Programs: Oversee employee training curricula, ensuring all staff are qualified, compliant, and prepared for evolving processes or regulatory changes.
• Drive Process Improvement: Proactively identify workflow bottlenecks, elevate document control best practices, and implement scalable solutions across the organization.
• Lead Digital Transformation: Act as the Business System Owner for electronic document and training management systems, overseeing system configuration, validation, and integrity per regulatory standards (21 CFR Part 11).
• Support Audits and Inspections: Represent quality systems during FDA/EMA audits, regulatory inspections, and customer visits, and deliver improvement strategies to leadership.
• Collaborate Cross-Functionally: Work closely with QA, Manufacturing, Regulatory, IT, and Engineering teams to drive seamless quality operations and support remediation efforts as needed.
• Uphold Culture and Standards: Set clear policies and productivity benchmarks, promote ethical practices, and cultivate a strong culture of operational excellence and compliance company wide.

Qualifications:

• Bachelor’s degree in Science, Engineering, or related field, Master’s degree strongly preferred.
• 8+ years of QA experience in a GMP-regulated environment.
• 3+ years of people management experience.
• Extensive knowledge of cGMP (21 CFR 210/211), EU GMP, GDP, 21 CFR Part 11, and ALCOA data integrity principles.
• Demonstrated expertise as a Business System Owner for digital Document Control/Training systems.
• Proven experience supporting successful regulatory inspections and customer audits.
• Superior project management, change leadership, and communication skills.

At NiCE, we don’t limit our challenges. We challenge our limits. Always. We’re ambitious. We’re game changers. And we play to win. We set the highest standards and execute beyond them. And if you’re like us, we can offer you the ultimate career opportunity that will light a fire within you.

At NiCE, we are a global leader in AI-powered customer experience solutions, helping organizations transform how they engage with customers across every interaction. Our unified cloud platform, CXone Mpower, enables enterprises to manage and optimize 100 percent of customer engagements across voice and digital channels, combining contact center capabilities with advanced analytics, automation, and conversational AI. As an AI-first company, NiCE is advancing the next generation of intelligent, automated customer interactions through generative AI, virtual agents, and real-time decisioning to drive improved satisfaction, efficiency, and loyalty at scale. NiCE also offers complementary compliance and public sector solutions that extend our AI capabilities into regulated and mission‑critical environments. With more than 25,000 customers worldwide, including 85 of the Fortune 100, NiCE operates in over 150 countries. Learn more at the Role

As a Senior Legal Counsel on NiCE’s Americas Legal team, you will support high‑value commercial and technology transactions that are central to NiCE’s customer experience business. The role is focused on enabling growth of NiCE’s CXone Mpower platform through the negotiation and structuring of complex technology, SaaS, and strategic partnership agreements. You will work closely with sales, product, finance, security, and privacy stakeholders to address issues at the intersection of cloud technology, data protection, and regulatory compliance, while providing practical, business-oriented legal guidance.

In addition to transactional responsibilities, you will contribute to the development of scalable contracting processes, legal playbooks, and operational improvements to support a rapidly growing and evolving business. Reporting to the Associate General Counsel for NiCE Americas, this hybrid role requires two days per week in the office and offers the opportunity to operate as a trusted legal advisor within a global, AI‑driven customer experience organization.

We are seeking a senior legal professional who demonstrates the following attributes:

• 
  
• Strategic and Commercial Mindset: Approaches legal issues with strong business judgment and creativity, delivering solutions that advance NiCE’s strategic and commercial objectives.
  
• Collaborative Partner: Works effectively across cross‑functional and geographically diverse teams, building trust and influence with stakeholders at all levels of the organization.
  
• Clear and Persuasive Communicator: Communicates complex legal concepts clearly and concisely, both in writing and verbally, with the ability to tailor messaging to different audiences.
  
• Proactive Problem Solver: Manages multiple priorities with minimal supervision, anticipates risks, and drives matters to completion in a fast‑paced, evolving environment.
  
• Adaptable and Resilient: Remains effective and composed amid change, ambiguity, and shifting business priorities.
  
• Team‑Oriented Professional: Values collaboration and contributes positively to a high‑performing, engaged legal team culture.
  

• 
  
• Lead Complex Transactions: Structure, negotiate, and manage sophisticated commercial and technology transactions across sales, product, and procurement, with a primary focus on enterprise cloud offerings.
  
• Provide Legal and Regulatory Guidance: Advise on U.S. and international legal issues related to SaaS, data protection, cybersecurity, and commercial contracting, delivering practical, risk‑balanced guidance to the business.
  
• Scale Legal Operations: Develop, maintain, and improve legal playbooks, templates, and contracting processes to increase efficiency and support a growing, fast‑moving organization.
  
• Partner Cross‑Functionally: Collaborate with legal colleagues and cross‑functional stakeholders globally to align legal strategies with business priorities and key initiatives.
  
• Anticipate Regulatory Change: Monitor and assess evolving laws and regulations affecting NiCE’s commercial activities and proactively advise on risk mitigation and compliance.
  
• Enable the Business: Educate and train internal teams on legal, compliance, and contracting best practices to support informed and efficient decision‑making.
  
• Build Trusted Relationships: Establish strong working relationships with internal stakeholders and external partners, balancing legal risk with commercial objectives.
  
• Support Strategic Growth: Contribute to initiatives that advance NiCE’s global growth strategy and innovation agenda.
  
• Other Legal Matters: Support additional legal projects and responsibilities as needed.
  

• 
  
• Education and Licensing: Juris Doctor with strong academic credentials and an active license to practice law in at least one U.S. jurisdiction.
  
• SaaS and Technology Experience: Minimum of 8 to 10 years of legal experience, with substantial experience supporting SaaS, cloud computing, and enterprise software transactions primarily on the vendor side.
  
• Transactional Expertise: Demonstrated experience drafting, negotiating, and advising on complex SaaS and technology agreements, including Data Processing Agreements and, where applicable, Business Associate Agreements.
  
• Legal Acumen: Strong working knowledge of data privacy, cybersecurity, and intellectual property law, including familiarity with U.S. and international data protection regimes and evolving regulatory trends.
  
• In‑House Experience: Prior in‑house legal experience supporting a commercial or technology‑driven business environment.
  

• 
  
• Public Company or Global Environment: Experience supporting a U.S. publicly traded company and/or a global, multinational organization.
  
• Operational Maturity: Proven ability to design, improve, and scale legal processes, templates, and playbooks in support of a growing business.
  
• AI and Emerging Technology Law: Familiarity with evolving artificial intelligence and automated decision‑making laws and regulations in the United States and internationally, including emerging global frameworks such as the EU AI Act.
  

• 
  
• Excellent negotiation, drafting, and communication skills, with the ability to translate complex legal issues into practical business guidance.
  
• Strong organizational skills and sound judgment, with the ability to manage multiple matters independently in a fast‑paced environment.
  
• Collaborative, team‑oriented approach with the ability to build effective working relationships across functions, regions, and cultures.
  

NiCE is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, age, sex, marital status, ancestry, neurotype, physical or mental disability, veteran status, gender identity, sexual orientation or any other category protected by law.

About the Position: Our client, an international Am Law 100 firm, has an active need for an investment management lawyer with fund formation experience to join the Corporate & Finance practice group in its Chicago office as a junior or mid-level associate. This practice group advises US, EU and other international clients across the full spectrum of their respective onshore and offshore alternative investment funds and corresponding strategies.

Highlights:

• 
  
• Nationally ranked as a Best Law Firm for Private Funds/Hedge Funds by Best Lawyers
  
• Ranked as a top 100 law firm by Vault Law
  
• Substantive associate training and mentoring
  
• Ranked among the top 10 firms for Client Service by BTI Consulting Group
  
• Ranked as one the best law firms for pro bono work by Vault Law
  

Responsibilities:

• 
  
• Handle transactions related to private investment funds, including fund formation, restructurings, joint ventures, and compliance matters
  
• Work with investors on structuring and negotiating potential investments in private funds
  

Required Qualifications:

• 
  
• 1-4 years of experience with private fund formation
  
• Exposure to the Investment Advisers Act of 1940 and/or the Investment Company Act of 1940
  
• Experience representing institutional investors and/or wealth advisory firms is a plus
  
• Excellent academic credentials
  

Location: Chicago, IL (Hybrid)

Compensation: The anticipated base salary range for this position is $225,000 – $310,000.

How will you make an impact?  

The Manager of Quality Control (QC) - Microbiology is responsible for overseeing the Quality Control strategies and operations, including but not limited to testing function in support of the development and testing services of Phase I-III and Commercial Microbiological testing and Environmental Monitoring functions. The QC Microbiology Manager assures compliance with GMP and company specifications as well as relevant pharmacopeia compendia. The Manager identifies areas for continuous improvement and/or implementation of industry best practices and drives implementation in the laboratory. The Manger keeps Head of Quality informed of all departmental activities and product-related events.

What will you do?

• Provides technical supervision and leadership of teams that are assigned to perform environmental monitoring, product release testing, routine, and non-routine microbiological testing.

• Collaborates with other departments to provide microbiology expertise and support for smooth running of GMP manufacturing operations.

• Oversight and maintenance of quality control microbiological testing program (including sterility, bioburden, identifications and Environmental Monitoring, and outsourced test laboratories).

• Participates and carries out continuous quality improvements in the QC laboratory.

• Identifies and resolves internal quality control microbiological testing issues.

• Ensures compliance with cGMP and safety requirements within the QC microbiological laboratory.

• Schedules and provides technical oversight of microbiological testing performed internally and externally sourced supporting GMP manufacturing and pre-Clinical activities and studies.

• Participates in project specific, system, client, and vendor audits.

• Participates in internal audits of GMP QC data and records, monitoring files and study files. Reviews new and executed documents for compliance to stated Pii SOPs, formats, and regulatory requirements (especially protocols, deviations, investigations, amendments, etc.)

• Writes and/or reviews SOPs pertaining to Quality Control microbiological operations, STM’s (standard test methods), and qualification and stability protocols (if needed) to insure appropriate codification of GMP procedures.

• Ensures QC microbiological laboratories and facilities are always in an audit ready status.

• Serves as a back up to QC client rep in meetings for microbiological matters.

• Acts as technical QC microbiological SME in support of client needs and projects and during third party inspections/audits.

• Interacts and communicates with customers to assure expectations are established, agreed to, and achieved.

• Engage actively with Project Management and other department functions to ensure the GMP programs are properly supported to achieve expectations; maintain effective and professional communication between all parties, including the customer.

• Identify, maintain, and report functional KPIs to site management.

• Perform other duties as assigned.

How will you get here?  

Education:  

• Bachelor’s degree, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.

Experience:  

• Preferred 15+ years relevant work experience in Quality Control laboratories

• Preferred three to five (10-15) years of leadership/ supervisory/management experience in commercial laboratory operations.

• 10 years of applied Microbiology experience in a commercial pharmaceutical, GMP manufacturing environment (preferably parenteral and in a CMO/CDMO/Clinical Environment)

• Experience in Analytical or Microbiological testing including Environmental Monitoring required

• Auditing and compliance experience in a biopharmaceutical or clinical research organization and/or federal regulatory experience is strongly preferred.

• Experience in a GMP environment to include ICH guidelines, FDA guidelines, USP and EP, and other applicable regulatory guidance’s (US and EU).

Knowledge, Skills, Abilities:  

• Must possess excellent communication and writing skills, patience, professionalism, and ability to effectively interact with staff and management alike (transversely collaborative) across functional groups and levels.

• Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.

• Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.

• Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.

• Must be able to comprehend and follow all applicable SOPs.

• Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.

• Demonstrate solid understanding on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.

• Good understanding of cGMPs, industry, and regulatory standards and guidelines.

• Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.

• Demonstrate the ability to portray the appropriate level of integrity and professionalism.

• Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.

• Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.

• Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.

• Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.

• Results-oriented and efficient.

• Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.

• Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).

• Demonstrate the ability to work well in a cross-functional team environment.

• Must communicate fluently in English and have legible handwriting.

Physical Demands:

• Ability to travel between and within facilities to visit staff, operations, and projects, as needed.

• Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).

• Ability to lift up to 40 pounds on occasion.

• Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).

What can Jabil offer you?

Along with growth, stability, and the opportunity to be challenged, Jabil offers a competitive benefits package that includes:

• Medical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options
• 401K Match
• Employee Stock Purchase Plan
• Paid Time Off
• Tuition Reimbursement
• Life, AD&D, and Disability Insurance
• Commuter Benefits
• Employee Assistance Program
• Pet Insurance
• Adoption Assistance
• Annual Merit Increases
• Community Volunteer Opportunities

Apply Today!

How will you make an impact?  

The Manager of Quality Control (QC) - Microbiology is responsible for overseeing the Quality Control strategies and operations, including but not limited to testing function in support of the development and testing services of Phase I-III and Commercial Microbiological testing and Environmental Monitoring functions. The QC Microbiology Manager assures compliance with GMP and company specifications as well as relevant pharmacopeia compendia. The Manager identifies areas for continuous improvement and/or implementation of industry best practices and drives implementation in the laboratory. The Manger keeps Head of Quality informed of all departmental activities and product-related events.

What will you do?

• Provides technical supervision and leadership of teams that are assigned to perform environmental monitoring, product release testing, routine, and non-routine microbiological testing.

• Collaborates with other departments to provide microbiology expertise and support for smooth running of GMP manufacturing operations.

• Oversight and maintenance of quality control microbiological testing program (including sterility, bioburden, identifications and Environmental Monitoring, and outsourced test laboratories).

• Participates and carries out continuous quality improvements in the QC laboratory.

• Identifies and resolves internal quality control microbiological testing issues.

• Ensures compliance with cGMP and safety requirements within the QC microbiological laboratory.

• Schedules and provides technical oversight of microbiological testing performed internally and externally sourced supporting GMP manufacturing and pre-Clinical activities and studies.

• Participates in project specific, system, client, and vendor audits.

• Participates in internal audits of GMP QC data and records, monitoring files and study files. Reviews new and executed documents for compliance to stated Pii SOPs, formats, and regulatory requirements (especially protocols, deviations, investigations, amendments, etc.)

• Writes and/or reviews SOPs pertaining to Quality Control microbiological operations, STM’s (standard test methods), and qualification and stability protocols (if needed) to insure appropriate codification of GMP procedures.

• Ensures QC microbiological laboratories and facilities are always in an audit ready status.

• Serves as a back up to QC client rep in meetings for microbiological matters.

• Acts as technical QC microbiological SME in support of client needs and projects and during third party inspections/audits.

• Interacts and communicates with customers to assure expectations are established, agreed to, and achieved.

• Engage actively with Project Management and other department functions to ensure the GMP programs are properly supported to achieve expectations; maintain effective and professional communication between all parties, including the customer.

• Identify, maintain, and report functional KPIs to site management.

• Perform other duties as assigned.

How will you get here?  

Education:  

• Bachelor’s degree, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.

Experience:  

• Preferred 15+ years relevant work experience in Quality Control laboratories

• Preferred three to five (10-15) years of leadership/ supervisory/management experience in commercial laboratory operations.

• 10 years of applied Microbiology experience in a commercial pharmaceutical, GMP manufacturing environment (preferably parenteral and in a CMO/CDMO/Clinical Environment)

• Experience in Analytical or Microbiological testing including Environmental Monitoring required

• Auditing and compliance experience in a biopharmaceutical or clinical research organization and/or federal regulatory experience is strongly preferred.

• Experience in a GMP environment to include ICH guidelines, FDA guidelines, USP and EP, and other applicable regulatory guidance’s (US and EU).

Knowledge, Skills, Abilities:  

• Must possess excellent communication and writing skills, patience, professionalism, and ability to effectively interact with staff and management alike (transversely collaborative) across functional groups and levels.

• Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.

• Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.

• Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.

• Must be able to comprehend and follow all applicable SOPs.

• Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.

• Demonstrate solid understanding on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.

• Good understanding of cGMPs, industry, and regulatory standards and guidelines.

• Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.

• Demonstrate the ability to portray the appropriate level of integrity and professionalism.

• Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.

• Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.

• Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.

• Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.

• Results-oriented and efficient.

• Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.

• Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).

• Demonstrate the ability to work well in a cross-functional team environment.

• Must communicate fluently in English and have legible handwriting.

Physical Demands:

• Ability to travel between and within facilities to visit staff, operations, and projects, as needed.

• Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).

• Ability to lift up to 40 pounds on occasion.

• Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).

What can Jabil offer you?

Along with growth, stability, and the opportunity to be challenged, Jabil offers a competitive benefits package that includes:

• Medical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options
• 401K Match
• Employee Stock Purchase Plan
• Paid Time Off
• Tuition Reimbursement
• Life, AD&D, and Disability Insurance
• Commuter Benefits
• Employee Assistance Program
• Pet Insurance
• Adoption Assistance
• Annual Merit Increases
• Community Volunteer Opportunities

Apply Today!