Openlane, EU Jobs in Usa

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.

Job Summary

We are seeking a detail-oriented Quality & Regulatory Specialist to support compliance, quality management, and regulatory activities. This role ensures adherence to international regulations and standards, supports product registrations, and maintains the company’s Quality Management System (QMS). This position requires strong knowledge of medical device regulations (e.g., FDA, EU MDR, ISO 13485) and excellent cross-functional collaboration.

Essential Duties and Responsibilities

• Regulatory Affairs
• Lead preparation, submission, and maintenance of global regulatory filings (FDA 510(k)/PMA, EU MDR Health Canada and other international registrations).
• Serve as primary contact with regulatory authorities, notified bodies, and certification agencies.
• Interpret evolving regulatory requirements and communicate strategic implications to leadership.
• Provide regulatory input on new product development, product changes, labeling, and marketing materials.
• Monitor regulatory changes and advise internal teams on impact to product development and market access.
• Quality Management System (QMS)
• Maintain and improve the QMS in compliance with ISO 13485, 21 CFR Part 820, and applicable standards.
• Support internal and external audits, inspections, and corrective actions.
• Ensure document control, training, and change management processes are properly implemented.
• Product Lifecycle Support
• Partner with R&D, manufacturing, and clinical teams to ensure design control, risk management, and post-market surveillance compliance.
• Review and approve quality/regulatory aspects of labeling, promotional materials, and product changes.
• Support vigilance reporting, complaint handling, and CAPA activities.
• Cross-Functional Collaboration
• Provide regulatory and quality guidance during new product development.
• Liaise with regulatory authorities, notified bodies, and certification agencies.
• Train employees on regulatory and quality compliance topics.
• Perform other duties as assigned by manager or supervisor

Experience & Education Requirements

• Bachelor’s degree in engineering, life sciences, regulatory affairs, or related field or equivalent work experience in those areas.
• 5-8 years of experience in quality and/or regulatory affairs in the medical device industry.
• Strong knowledge of ISO 13485, ISO 14971, 21 CFR Part 11/820, EU MDR 2017/745.
• Experience with regulatory submissions (FDA, EU, or other international markets).
• Excellent analytical, organizational, and communication skills.

Preferred Skills & Abilities

• Medical device industry experience
• Medical Device regulation requirements knowledge, as applicable to responsibilities
• Regulatory Affairs / Quality Assurance Certification (e.g., RAC, CQE, CQA) is a plus.

Job Title: Associate Director QARA

Department: Quality

Reports to:

Employment Type: Non-exempt

About NeuWave

NeuWave Medical develops image guided microwave ablation tools and software that enables physicians to treat tumors in a minimally invasive procedure.This technology allows patients to be treated in outpatient settings, reducing procedural complexity and recovery times. Our organization is excited to be embarking on numerous new development projects to further improve patient care, and we are looking for new teammates to help us on this inspired journey. You’ll join an interdisciplinary group of engineers who work closely with manufacturing, quality, regulatory, clinical, and strategic marketing professionals. This team highly values rapid experimentation and close collaboration with clinicians. Our culture blends friendly competition with genuine camaraderie—we move quickly, celebrate wins, and build lasting relationships while shaping the future of the business.

As part of NeuWave, you’ll have access to a comprehensive offering of competitive benefits. If you’re motivated by clinically meaningful problems, evidence driven development and building solutions at scale, NeuWave offers the chance to perform career defining work--with freedom to develop yourself within a progressive and growing healthcare company.

Position Summary

NeuWave is seeking a dynamic Associate Director of Quality Assurance & Regulatory Affairs (QA/RA) to lead and scale our quality and regulatory functions during a critical phase of transition and innovation. This role is responsible for establishing and maintaining compliant quality systems (ISO 13485, 21 CFR 820), overseeing regulatory approvals, leading audits, ensuring product safety, and partnering cross-functionally with R&D and Operations.

The Associate Director will drive a strong quality culture while overseeing full-time and contract staff across New Product Development & Lifecycle Quality, Quality Systems, Production & Service Quality, Supplier Quality, and Post-Market Surveillance. A key focus will be leading major transition initiatives, including standing up a new Quality System, implementing a new eQMS, and executing the 2025 functional business plan.

Key Accountabilities

• Lead and maintain a compliant Quality Management System (QMS) aligned with FDA, ISO 13485, EU MDR, and global regulatory standards; drive achievement of key quality metrics, including CAPA effectiveness.
• Oversee major transition initiatives, including implementation of a new QMS, eQMS deployment and validation, and migration of legacy quality systems.
• Serve as primary liaison to regulatory authorities (FDA, EU Notified Bodies); lead regulatory submissions, registrations, labeling compliance, and responses to inquiries.
• Ensure audit readiness and lead internal, third-party, and regulatory audits, including TÜV surveillance audits.
• Oversee product and lifecycle quality, including risk management, design controls, production quality, and post-market surveillance.
• Partner with R&D and Operations to support successful new product introductions and define regulatory pathways.
• Strengthening supplier quality and manufacturing performance, driving operational efficiency and Cost of Goods (COGs) improvements.
• Build and lead a high-performing QA/RA team while advancing a strong, business-aligned quality culture.

Education, Experience & Skills

• Education: Bachelor’s degree in Engineering, Science, or related field required; advanced degree preferred.
• Experience: 5+ years in QA/RA within regulated industries, including leadership experience.
• Regulatory Expertise: Strong knowledge of FDA 21 CFR Part 820, ISO 13485, GMP, and global submission processes (510(k), PMA, EU MDR).
• Leadership: Proven ability to lead cross-functional quality teams across production, systems, and post-market activities.

Location

This position will be based in Madison, Wi. Relocation assistance may be available for the preferred candidate.

Equal Opportunity Employer

NeuWave Medical is an equal opportunity employer. We are committed to creating an inclusive environment and do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected status.

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.

At Afton Scientific, every role contributes to advancing the quality and reliability of sterile pharmaceutical manufacturing. Our team is driven by innovation, collaboration, and a commitment to excellence. We support employees at every stage of their career by fostering an environment where development, learning, and meaningful impact are possible.

We invite you to explore opportunities to join our organization and contribute to our mission. We are currently seeking a Quality Control Supervisor to support our growing biopharmaceutical operations at our on-site facility in Charlottesville, Virginia.

Overview of this Position:

The QC Analytical Chemistry Supervisor is responsible for the oversight, performance, and continuous improvement of analytical testing in support of pharmaceutical manufacturing operations. This role supervises daily QC laboratory activities, supports analytical staff, ensures adherence to pharmacopeial and regulatory requirements, and provides technical guidance on method execution, data integrity, and laboratory compliance. This position also contributes to method development and qualification, oversees laboratory instrumentation and maintenance schedules, participates in audits, and ensures accurate review and documentation of laboratory operations in alignment with FDA, ICH, USP, EU, and related quality expectations.

Non-Negotiable Requirements:

• Bachelor’s degree in chemistry or a closely related scientific discipline

•Minimum 5 years of experience in pharmaceutical analytical testing in a cGMP environment, including hands‑on operation of HPLC, GC, FTIR, KFT, UV‑Vis, and similar technologies

•Demonstrated experience in regulated laboratory settings (FDA/ICH/USP), including strong understanding of data integrity (ALCOA+) and cGMP compliance

•Proficiency in reviewing and approving laboratory documentation (SOPs, deviations, OOS/OOT/OOE/NCMR, protocols, reports)

•Strong background in chromatography and experience using Empower

•Experience with raw material testing, stability testing, and LIMS

•Strong written and verbal communication skills

Preferred Requirements:

• Experience supervising or mentoring laboratory personnel

• Experience supporting regulatory or client audits

•Strong technical troubleshooting abilities with analytical methods or laboratory equipment

Responsibilities Include:

• Develop, implement, and maintain HR policies and procedures to support organizational compliance •Supervise daily QC Analytical Chemistry Laboratory operations related to production support, testing activities, and staff oversight

•Provide guidance to laboratory staff and assist in the management and development of QC analytical personnel as directed by the QC Manager

•Execute and oversee cGMP‑compliant analysis of raw materials, APIs, and pharmaceutical finished products using pharmacopeial and regulatory methods (USP, NF, JP, EU, FDA, ICH)

•Ensure proper design, execution, documentation, and validation of analytical techniques, instrumentation, and test methods used in the laboratory

•Review executed laboratory operations for accuracy, completeness, and compliance with internal SOPs and external regulatory expectations

•Oversee equipment calibrations, verifications, and preventative maintenance activities for laboratory instrumentation and supporting equipment

•Identify technical issues and lead independent troubleshooting efforts, providing follow‑up and solutions to management as needed

•Participate in client and regulatory audits as a QC representative and maintain professional, prepared communication with external partners and internal teams

•Write, review, or approve SOPs, validation protocols, specifications, and investigation reports as applicable (e.g., OOS, OOT, ODR, NCMR)

•Assist with procurement of laboratory equipment and supplies and contribute to process improvements within the QC laboratory

The duties listed above are intended to describe the essential functions of this position. Additional responsibilities may be assigned as needed. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this job. This role may require sitting, standing, or walking for extended periods; using a computer; and working in a standard office environment. Specific physical or environmental requirements will be addressed through the reasonable accommodation process. We are an equal opportunity employer. We do not discriminate based on disability and will provide reasonable accommodation as required by law.

Senior Manufacturing Process Engineer

Meet has partnered with an exciting Stealth start-up in the Brain-Computer Interface (BCI) space based in the San Francisco Bay area. The company is developing cutting-edge medical devices and technology for the treatment of unmet neurological disorders. The Head of Operations is seeking an experienced Manufacturing Process Engineer to support NPI of electro-mechanical devices in collaboration with suppliers.

This role will focus on hands-on interaction with suppliers to develop manufacturing processes, tooling, and documentation, from design feasability through commercial release. This role will require real-time engagement and technical support of suppliers, and this individual will be expected to travel often to domestic supplier sites and occasionally to international suppliers.

Primary Responsibilities:

• Serve as the primary technical liaison to external manufacturing partners, ensuring successful delivery of components, assemblies, and finished devices
• Collaborate with product development teams to ensure designs are manufacturable and compliant with medical device quality system requirements
• Develop and maintain manufacturing documentation, including work instructions, process flows, and validation protocols
• Support supplier implementation of specifications, manufacturing processes, and quality requirements
• Lead and participate in process validation activities including IQ/OQ/PQ, PFMEA, and failure investigations
• Drive continuous improvement initiatives related to manufacturing efficiency, quality, cost, and scalability
• Support resolution of non-conformances and corrective actions with suppliers
• Ensure manufacturing activities comply with applicable regulatory requirements (FDA, ISO 13485, EU MDR, etc.)
• Provide hands-on technical support to suppliers, including travel as needed (domestic and international)

Role Requirements:

• B.S. in relevant engineering discipline, or equivalent experience.
• 10 or more years of medical device manufacturing experience, preferably in senior roles at start-up companies developing and manufacturing electro-mechanical devices.
• Experience with active implantable systems (Implant, Leads, Externals, etc.).
• Experience with medical device manufacturing including molding, laser welding, clean room assembly, packaging, labeling, and sterilization.
• Experience with electronic manufacturing and test including PCB fab, PCA assembly, microelectronics assembly, flip chip, in circuit test (ICT) and functional test.
• Experience with manufacturing automation.
• Experience in defining and executing process validation activities.
• Experience collaborating with internal customers and external partners.
• Understanding of and experience implementing validating manufacturing processes for medical devices in accordance with FDA and EU Requirements.
• Experience with Solidworks, Labview / manufacturing process and test automation software.
• Ability to travel to Domestic and International supplier sites frequently

About Made Scientific

Made Scientific is a leading US-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.

Position Summary

The Sterility Assurance Program Lead (Associate Director) is a quality and technical leader responsible for establishing, maintaining, and continuously improving a robust sterility assurance and contamination control program across GMP cell therapy operations, from clinical through commercial stages. Reporting to the VP of Quality and Compliance, this individual will work in close partnership with Technical Operations, QC, Site Quality Operations, Plant Operations, and MSAT to ensure consistent aseptic execution, clear functional accountability, and sustained compliance with global regulatory expectations for advanced therapies.

Key Responsibilities

Sterility Assurance & Contamination Control Program

• Design, implement, and sustain a comprehensive Sterility Assurance and Contamination Control Strategy (CCS) aligned with global GMP expectations for cell therapy manufacturing.

• Ensure sterility assurance principles are embedded across facility design, equipment, processes, personnel practices, and quality systems for both clinical and commercial operations.

• Maintain alignment with applicable regulations, including 21 CFR Parts 210/211, 1271, EU GMP Annex 1 & 2, ICH guidance, and evolving global expectations for ATMPs.

Aseptic Operations & Functional Ownership

• Define and govern clear functional ownership of sterility assurance activities across Technical Operations and Quality functions.

• Provide oversight to ensure appropriate independence, compliance, and cross-functional collaboration.

Environmental Monitoring & Data Oversight

• Oversee the design and maintenance of Environmental Monitoring (EM) programs, including EMPQ, EMRA, sampling plans, alert/action limits, and response strategies.

• Review EM trends and contamination indicators to maintain a sustained state of control.

• Lead cross-functional discussions on EM excursions, contamination events, and risk mitigation.

Aseptic Process Validation & Risk Management

• Provide sterility assurance leadership for aseptic process simulation and validation.

• Oversee media fill design, execution, and failure investigations.

• Lead contamination risk assessments for process changes, new equipment, facility modifications, or tech transfers.

• Drive root cause analysis and CAPA development related to sterility assurance events.

Quality Systems Interface & Continuous Improvement

• Author, review, and approve SOPs, policies, and standards related to sterility assurance and contamination control.

• Partner with Quality Systems to embed sterility assurance into deviation management, change control, CAPA, and training systems.

• Analyze sterility assurance trends to identify systemic risks and drive continuous improvement.

• Support sterility readiness for new site start-ups, expansions, tech transfers, and product launches.

Regulatory Inspections & Audit Support

• Act as Sterility Assurance SME during regulatory inspections, client audits, and internal audits.

• Lead inspection preparation, including gap assessments, mock audits, and SME coaching.

• Lead or support response drafting for sterility-related findings, including 483s, regulatory commitments, and client observations.

Leadership, Influence & Collaboration

• Provide mentorship and leadership to sterility assurance SMEs across sites.

• Influence and align stakeholders across Quality, Technical Operations, QC, MSAT, Facilities, and Program Management.

• Advise senior leadership on sterility assurance risks, contamination trends, and program maturity.

• Champion a proactive, science-based, and inspection-ready sterility assurance culture.

Required Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Microbiology, Engineering, or related field.

• 10+ years of progressive experience in GMP-regulated cell therapy, gene therapy, biologics, or advanced therapy manufacturing.

• Deep expertise in aseptic processing and sterility assurance for non-terminally sterilized products.

• Strong working knowledge of global GMP regulations (FDA, EMA, ICH, Annex 1).

• Demonstrated experience supporting clinical and commercial GMP operations.

• Proven ability to lead cross-functional programs and influence without direct authority.

• Strong communication skills for diverse audiences, from operators to regulators.

• Experience leading or supporting inspections, client audits, and internal audits.

• Flexibility to work variable hours to support operations and inspections.

• Strong organizational skills and ability to manage competing priorities.

Preferred Qualifications

• Experience working in a CDMO with multiple clients and programs.

• Direct experience with EU Annex 1 implementation and contamination control strategy.

• Experience supporting late-stage to commercial transitions or high-growth environments.

• Certification or training in microbiology, aseptic processing, Lean, or Six Sigma.

Education Requirement

• B.S. in a related field required.

Physical Requirements

• Ability to perform job functions in compliance with all standards, including productivity and attendance.

• Willingness to work in CNC/ISO7-8 cleanroom environments.

• Ability to lift up to 25 lbs.

• Must be able to stand, bend, and perform physical tasks in manufacturing environments.

• Comfortable working with cell-based products and chemicals.

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.

Want to Expand

your career-development potential,

your ability to help donors and patients,

and your access to professional opportunities?

We’re growing fast.

[You can, too!]

There are so many ways Octapharma Plasma can enhance your life and your career. Our strong growth is creating great learning and career development opportunities throughout our company, and especially our donation centers. Because you’re someone who loves to learn, enjoys people, and has a real heart to help, we encourage you to join us as a: Validation Technician

This is What You’ll Do

• Develops and maintains equipment validation policy and adheres to regulatory requirements.
• Performs the development and execution of process validation protocols and documents consistent with FDA and EU guidelines.
• Ensures regulatory requirements are met during development and execution of equipment validation protocols.
• Develops, executes, and maintains validation protocols for donor center, laboratory, and plasma storage warehouse equipment - including freezers, refrigerators, Anti-D refrigerators, and supply room temperature mapping - ensuring alignment with cGMP, GAMP, and good engineering practices.
• Develop protocols for temperature studies (e.g., plasma thawing, volume changes, collection process modifications)
• Analyzes resulting data to ensure product quality and compliance with regulatory standards.
• Reviews, approves, and summarizes executed validation protocols, investigates deviations, and ensures timely resolution of nonconformities.
• Maintains strict adherence to the organization’s SOPs, FDA and EU regulations, and state/local laws governing equipment validation and plasma storage quality.
• Performs other duties as assigned.

This is What it Takes

• Three (3) years’ experience biologics, drug manufacturing, or medical device industry or FDA regulated laboratory.
• One (1) year of validation or relatable experience in regulated industry.
• Prior use of use of equipment: calibrated, temperature monitoring, data loggers, etc. preferred
• Ability to travel up to 40%.

Physical Requirements

• Position works at donation centers fleetwide
• Ability to view video display terminal images 18” away from face for extended periods of time
• Ability to sit for extended periods of time
• Ability to use a computer and other office equipment
• Ability to occasionally lift and carry up to 20 pounds
• Ability to reach, bend, and stoop as necessary
• Ability to communicate effectively, both verbally and in writing
• Ability to focus and concentrate on tasks for extended periods
• Ability to navigate the office environment safely, including stairs and elevators (if applicable)
• Ability to travel up to via airplane or vehicle
• Ability to use assistive devices if needed for mobility or communication
• Ability to work in temperature-controlled environments, including temperatures as low as -40C

Do Satisfying Work. Earn Real Rewards and Benefits

We’re widely known and respected for our benefits and for leadership that is supportive and hands-on. Managers who truly want you to grow and excel.

• Formal training
• Outstanding plans for medical, dental, and vision insurance
• Health savings account (HSA)
• Flexible spending account (FSA)
• Tuition Reimbursement
• Employee assistance program (EAP)
• Wellness program
• 401k retirement plan
• Paid time off
• Company paid holidays
• Personal time

With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch.

Interested? Learn more online and apply now at:

And if you know someone else who'd be a great fit at Octapharma Plasma, Inc. please forward this post