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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.

Position Summary

The Senior Quality Assurance Specialist is responsible for the review, approval, and compliance oversight of GMP documentation supporting manufacturing operations and process validation activities. This role partners closely with Manufacturing Sciences & Technology (MS&T) and Manufacturing teams to ensure timely batch record, BOM, and technical document approvals while maintaining compliance with U.S. and EU cGMP regulations.

Key Responsibilities

• Review and approve GMP documentation supporting manufacturing operations, including Master Batch Records, Solution Records, Equipment Preparation Records, Process Assembly Records, Test Sampling Plans, and other manufacturing records as required.
• Collaborate with MS&T and Manufacturing to support BOM review, approval, and release within ASCTrac and SAP systems to ensure production timelines are met.
• Review and approve technical documents associated with process validation and manufacturing operations, including but not limited to:
• Process Characterization
• Process Performance Qualification (PPQ)
• Resin and Membrane Qualifications
• Non-routine Sample Plans
• Provide general QA support to manufacturing operations, including participation in deviation investigations, CAPA development, procedure reviews, and change control assessments, as required.
• Perform compliance review of executed batch records and internal support records to ensure adherence to cGMP and internal quality standards.
• Attend relevant project and operational meetings.
• Support client audits, client meetings, regulatory inspections, and process improvement initiatives as needed.

Qualifications:

• Bachelor’s degree with 10+ years of experience, or Master’s degree with 8+ years of experience, in a QA role within a cGMP-regulated biopharmaceutical (or equivalent) environment.
• Demonstrated experience supporting Manufacturing Process Operations and validation activities in a QA capacity.
• Strong knowledge of U.S. and EU cGMP regulations and guidelines.
• Working knowledge of electronic quality management systems and manufacturing execution systems.
• Working knowledge of electronical management systems
• Familiarity with Operational Excellence principles.

The Calibration Technician is responsible for performing routine and non-routine calibration of instruments and equipment used at the Client's facility. This role ensures that all critical systems operate within specified tolerances and comply with regulatory standards, including FDA, EU, GMP, and ISO guidelines.

Essential Duties and Responsibilities:

· Perform scheduled and unscheduled calibrations on a wide range of instruments, including pressure gauges, temperature sensors, balances, pH meters, and cleanroom monitoring devices, among others, and document properly in the CMMS.

· Maintain accurate and complete calibration records in compliance with cGMP and internal quality standards.

· Troubleshoot and resolve calibration issues, including out-of-tolerance (OOT) conditions, and escalate as necessary.

· Support investigations, deviations, CAPA, and change control processes related to calibration activities.

· Ensure calibration standards and reference instruments are maintained and traceable to national/international standards.

· Assist in the preparation for internal and external audits by providing calibration documentation and technical support.

· Collaborate with Quality Assurance, Maintenance, and Production teams to ensure equipment readiness and compliance.

· Follow and contribute to the development and revision of Standard Operating Procedures (SOPs) related to calibration.

· Maintain calibration schedules and ensure timely execution to prevent overdue equipment.

· Adhere to all safety, environmental, and contamination control procedures in sterile and cleanroom environments.

· Assist with calibration SOP revisions.

· Work with data acquisition and validation equipment (e.g., process control equipment/controllers, Dataloggers, DC Analog/Signal Conditioners, and transducers).

· Troubleshoot, inspect, and repair test and measurement equipment in support of new projects.

· Provide on-site calibration support for equipment that is either too sensitive to move or is too large and not feasible to relocate.

· Work overtime when necessary to support high-priority requests or meet project goals.

· Perform preventative maintenance tasks related to calibration activities.

· Maintain a safe work environment; work in a safe manner following all safety SOP’s and wear Personal Protective Equipment as required.

· Able to work safely in an environment containing hazardous chemicals, high and low temperature liquids, high-pressure liquids and gases, steam, and moving machinery.

· Able to check, respond to, and troubleshoot Equipment Monitoring System (EMS) & Building Management Systems (BMS) issues and alarms.

Basic Qualifications and Capabilities:

· Associate's degree or technical certification in Instrumentation, Electronics, Engineering Technology, or related field.

· Minimum of 2+ years of calibration experience in a GMP-regulated pharmaceutical or biotech environment.

· Understanding of calibration principles, metrology, and regulatory compliance (FDA, EU GMP, ISO 17025).

· Excellent documentation and communication skills.

· Proficiency with calibration management systems (e.g., CMMS, Blue Mountain, Maximo)

· Ability & experience reading schematics, wiring diagrams & other technical documents.

Preferred Qualifications:

· Exceptional organizational and teamwork skills are required to be successful in this dynamic environment with changing priorities.

· Experience with regulatory inspections.

· Experience with continuous improvement/lean tools such as Six Sigma, 5-S, Lean Manufacturing, Transactional Lean, etc.

Immediate need for a talented R&D Project Manager. This is a 12+ months contract opportunity with long-term potential and is located in San Diego, CA(Hybrid). Please review the job description below and contact me ASAP if you are interested.

Job ID:26-08555

Pay Range: $60 - $90/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Lead and manage multiple R&D programs and/or large-scale product development projects, from feasibility through commercialization, including Class II and/or Class III medical devices (with emphasis on electrically active/medical electrical equipment where applicable).
• Develop and maintain integrated program plans, timelines (Gantt charts), budgets, resource plans, and risk registers; proactively identify and mitigate risks across technical, regulatory, clinical, commercial, and electrical safety dimensions.
• Define project scope, objectives, deliverables, and success criteria; create and maintain project charters, work breakdown structures (WBS), and detailed schedules.
• Lead cross-functional core teams (R&D/Engineering, Quality, Regulatory Affairs, Clinical, Manufacturing, Marketing, and Operations) to execute program objectives; facilitate effective decision-making and resolve conflicts.
• Drive adherence to Design Control processes (21 CFR 820.30), risk management (ISO 14971), usability engineering (IEC 62366), basic safety and essential performance requirements for medical electrical equipment (IEC 60601-1 series), and other applicable standards throughout the product lifecycle.
• Provide regular status updates, executive-level reporting, and dashboards to senior leadership and stakeholders; communicate program progress, issues, decisions, and changes clearly and proactively.
• Support regulatory strategy development and submissions (e.g., 510(k), PMA, technical files for CE marking), including coordination of electrical safety testing, EMC compliance (IEC 60601-1-2), and collateral/particular standards as needed.
• Foster a collaborative, innovative, and compliant culture within program teams.
• Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and cross functional teams management.
• Lead cross-functional teams through identification of risks & mitigations, problem resolution and root cause analysis, corrective and preventive action.
• Develop and maintain integrated project plan with risk-based timeline, critical path milestones, resource allocation, roadmap with clear milestones for gap analysis, risk management, remediation, testing, certification and budget tracking to support certification goals
• Monitor the effectiveness and performance of the launch and project team and facilitate the development of contingency plans, recommending corrective actions as required.
• Ensure compliance with quality management systems and regulatory requirements, where applicable.
• Lead the team to prepare for and execute Phase Gate. Represent the team with Client leaders, ensuring such decisions are informed by a balanced and clearly articulated representation of the relevant data.
• Leverage technical acumen to partner with engineering teams, monitor development progress, and ensure alignment between technical deliverables and program timelines
• Drive design control discipline throughout product development, ensuring compliance
• Conduct or oversee gap assessments against general, collateral, and particular standards for medical electrical equipment safety and essential performance.
• Manage integrated risk management (per ISO 14971), including essential performance definition, hazard analysis, risk controls, and verification.
• Coordinate and manager the execution of test plans for electrical safety, EMC, mechanical, environmental, and essential performance requirements; coordinate pre-compliance and formal third-party testing.
• Oversee compliance documentation: technical files, risk management files, test reports, essential performance rationale, and certification justification.
• Integrate compliance activities with the quality management system (ISO 13485) and other regulatory requirements (FDA, EU MDR, etc.).
• Serve as primary liaison with notified bodies, test labs, and regulatory consultants to support certification and post-compliance needs.
• Drive a safety-focused culture while ensuring the team meets the September 2027 compliance target

Key Requirements and Technology Experience:

• Key Skills;Bachelor’s degree in Engineering (Biomedical, Electrical, Mechanical, or related),Life Sciences, or equivalent.
• 3-5 years of project management in medical devices, with ≥5 years leading compliance programs for medical electrical equipment.
• Proven track record of successfully delivering medical device programs from concept to market launch (including regulatory clearance/approval).
• Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971 risk management, IEC 62304 (software), and global regulatory pathways (510(k), De Novo, PMA, MDR).
• Proficiency with project management tools (e.g., MS Project, Jira, Smartsheet, or similar) and standard office software.
• Project Management Professional (PMP) certification not required but is preferred
• Scrum Master and SAFE Agile certification is preferred.
• Experience in medical device industries required, including experience in FDA or other regulated environments.
• Knowledge of the medical device industries beneficial integrating science and technology into business processes.
• Technical background in electrical, mechanical, or biomedical engineering
• Expert in the development and deployment of program management tools and techniques including methods for tracking progress, risk management and delivery of major milestones.
• Understanding of engineering development lifecycles and the ability to translate technical inputs into program-level actions and timelines
• Excellent influencing skills with the ability to achieve challenging goals through others without direct authority across different functions, external partners, geographies, and cultures.
• Drive for accountability within self and others.
• Proven project management experience with delivering medium-to large-scale projects in managed service model from concept through delivery and operations
• Relentless advocacy for the customer with a focus on meeting or exceeding customer requirements.
• Driving the team to make trade-offs that optimize customer and business value while maintaining program velocity and outcomes that sustain the highest standards of quality.
• Direct experience with major test labs and certification bodies for medical electrical equipment standards.
• Experience with programmable electrical medical systems (PEMS) or software-inclusive devices (IEC 62304 knowledge a plus)
• Proven success taking Class II (or higher) active medical electrical devices from gap assessment through third-party certification.
• Strong knowledge of ISO 14971, ISO 13485, general/collateral/particular standards for medical electrical safety and essential performance, and EMC requirements.
• Familiarity with FDA QSR (21 CFR Part 820), EU MDR/IVDR, or other global regulations.

Our client is a leading Pharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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The Director of Quality Operations is a critical leadership position responsible for ensuring the highest standards of quality and compliance in the sterile drug manufacturing process. This individual will lead and oversee key quality operations functions, while ensuring alignment with customer & regulatory requirements and company objectives. The role requires a blend of technical expertise, analytical thinking, and leadership skills to address challenges, optimize processes, foster a culture of continuous improvement across the organization and enhance client relationships.

This role is responsible to:

• Ensure compliance with cGMP, FDA, and other applicable regulatory requirements for sterile drug manufacturing.
• Lead the team in quality oversight of manufacturing processes, ensuring adherence to SOPs and quality standards.
• Drive initiatives to strengthen aseptic technique, contamination control strategies, and data integrity practices.
• Support the development and maintenance of a robust risk management program, ensuring all critical issues are addressed with sustainable solutions.
• Serve as the quality operations representative during internal and external meetings with clients and other entities.
• Respond to client inquiries, quality concerns, and requests in a timely and professional manner.
• Oversee the resolution of client-related deviations, investigations, and CAPAs, ensuring timely closure.
• Provide root cause analysis and implement preventive measures for recurring client concerns.
• Lead cross-functional teams to ensure effective resolution of quality issues impacting clients.
• Facilitate effective communication between clients and internal stakeholders to ensure alignment on quality objectives.
• Keep abreast of changes to quality regulations and guidelines, advise the management team of any business implications of these changes
• Maintain a detailed and comprehensive understanding of FDA, EU and other regulatory agency requirements
• Conduct all work in compliance with FDA, 21 CFR 820, 21CFR 210 and 211 and other regulatory agency requirements
• Lead and direct work and provide feedback to a team of QA Specialists
• Lead, manage and ensure proper training to any relevant change management programs throughout the company

This role requires eight to ten (8-10) years of progressively responsible related quality assurance experience along with a Bachelor's Degree. Subject matter expertise in FDA, EU, and other regulatory agency requirements. Comprehensive knowledge of QA concepts and principles. Knowledge of cGMP principles and RCA tools.

Position Summary

Meet has partnered with a growing pharmaceutical manufacturing organization supporting sterile injectable and biopharmaceutical products. The company is seeking a Senior Validation Engineer to lead and execute validation activities across manufacturing operations.

This individual will ensure that facilities, utilities, equipment, computerized systems, and processes are designed, installed, qualified, and maintained in a validated state in compliance with FDA, EU GMP, ICH, and other global regulatory requirements. The role will also provide technical leadership and subject matter expertise in aseptic processing, cleanroom environments, and contamination control strategies.

Key Responsibilities

Validation & Qualification

• Lead and execute DQ, IQ, OQ, and PQ activities for aseptic filling lines and isolators/RABS, autoclaves, SIP/CIP systems, lyophilizers, sterile filtration systems, cleanrooms, and classified areas
• Author, review, and approve validation protocols; support execution, interpret data, and generate final reports
• Develop and maintain Validation Master Plans (VMPs)
• Support process validation, cleaning validation, and aseptic process simulations (media fills)
• Lead validation of critical utilities including Water for Injection (WFI), clean steam, HVAC systems, and compressed gases (CDA, nitrogen)
• Perform environmental qualification and airflow visualization (smoke studies)
• Validate computerized systems in accordance with GAMP 5 and 21 CFR Part 11
• Ensure data integrity compliance in alignment with ALCOA+ principles
• Support automation and control systems validation (PLC, SCADA, etc.)
• Ensure compliance with FDA cGMP (21 CFR Parts 210/211) and EU GMP Annex 1
• Support regulatory inspections, customer audits, and audit responses

Technical Leadership & Continuous Improvement

• Act as a Subject Matter Expert (SME) in validation and sterile manufacturing environments
• Lead change controls, deviations, CAPAs, and risk assessments (e.g., FMEA)
• Drive continuous improvement initiatives to enhance compliance, efficiency, and operational robustness

Qualifications

• Bachelor’s degree in Engineering or related Life Sciences field
• Strong technical writing and documentation skills
• Proficiency with Microsoft Office (Word, Excel, PowerPoint)

Experience

• 3+ years of hands-on validation experience within sterile injectable pharmaceutical or biopharmaceutical manufacturing environments

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.