Director of Quality Assurance, Cell Therapy

Job Description

Job Description

Kelly® Science & Clinical is currently recruiting for a Director of Quality Assurance for a direct hire opportunity with a global life sciences company at their San Jose, CA facility. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology realm.
Workplace: Onsite in San Jose, CA
Position Title: Director of Quality Assurance
Position Type: Direct hire
Salary range: $210,000-250,000/year
Our client is a global life sciences organization supporting the development and manufacture of innovative therapies for both internal and external partners. Its Northern California site is expanding its capabilities across the product lifecycle, from GMP starting materials and intermediates through the manufacture and release of patient-ready drug products.
We are seeking an accomplished, strategic, and hands-on Head of Quality to lead Quality Operations, Quality Systems, and CMC Quality oversight for the site. This is a high-impact leadership opportunity for an experienced quality professional who can strengthen organizational capability, advance inspection readiness, and help enable the successful delivery and commercialization of complex biopharmaceutical products.
The successful candidate will serve as a trusted advisor to site and global leadership, customers, regulatory authorities, and cross-functional partners. They will be accountable for maintaining a robust, scalable quality culture while supporting technical transfers, client programs, regulatory submissions, and commercial manufacturing activities.
Key Responsibilities
Quality Strategy and Site Leadership

• Develop and execute the site’s quality and compliance strategy in alignment with business objectives and global quality standards.
• Provide strategic and operational leadership for:
  • Quality Operations
  • Quality Systems
  • CMC Quality
  • Inspection readiness
  • Compliance and continuous improvement programs
• Establish and maintain a culture of quality, accountability, scientific rigor, and continuous improvement.
• Advise site leadership and functional stakeholders on regulatory strategy, quality risk, product quality, and operational compliance.
• Lead global quality and compliance initiatives as assigned.

Quality Systems and Compliance

• Maintain an effective, risk-based Quality Management System that ensures products and processes meet internal standards, customer expectations, current GMP requirements, and applicable regulatory guidelines.
• Oversee QMS performance, including deviations, CAPAs, change controls, investigations, complaints, training, documentation, and associated quality metrics.
• Ensure quality activities are appropriately resourced, prioritized, and completed in accordance with established timelines.
• Provide expert interpretation of applicable regulations, agency guidance, pharmacopeial requirements, and internal policies.
• Maintain continuous inspection readiness and ensure timely completion of regulatory commitments, inspection responses, audit responses, and remediation activities.
• Establish and monitor Quality KPIs, using data and risk-based insights to drive sustainable improvements.

Regulatory, Audit, and Customer Oversight

• Serve as the senior quality representative during health authority inspections, customer audits, partner interactions, and internal audits.
• Lead preparation for and execution of regulatory inspections and client audits, including response development and commitment management.
• Provide QA leadership and review of CMC content supporting IND, BLA, and related regulatory submissions for internal and client-sponsored programs.
• Review and approve responses to questions from regulatory authorities, including the U.S. Food and Drug Administration.
• Build strong, credible relationships with customers, regulatory agencies, global manufacturing sites, and internal stakeholders.

Manufacturing, CMC, and Product Quality

• Provide quality oversight across the manufacturing network, from GMP starting materials and in-process intermediates through labeled, patient-ready drug products.
• Own or oversee QA disposition and release decisions for applicable materials, intermediates, and finished products.
• Provide quality leadership for manufacturing processes, analytical methods, laboratory operations, technical transfers, validation activities, and new product introductions.
• Support client commercialization programs and ensure quality deliverables align with program milestones and customer commitments.
• Partner with Technical Operations, Manufacturing, QC, Engineering, Regulatory Affairs, and Supply Chain to identify and manage quality risks.
• Ensure new product and technical transfer activities meet quality, compliance, and project timeline requirements.

People Leadership and Organizational Development

• Build, lead, and develop a high-performing Quality organization capable of supporting a growing, technically complex manufacturing environment.
• Define clear team and individual objectives, monitor progress, and maintain accountability for results.
• Recruit, retain, coach, and develop talent through meaningful feedback, training, mentoring, and career development opportunities.
• Strengthen technical depth, leadership capability, and succession planning across the Quality function.
• Model the organization’s values and behaviors through visible, collaborative, and ethical leadership.
• Demonstrate flexibility when business priorities require extended or adjusted working hours.

Required Qualifications and Experience

• Bachelor’s degree in a scientific or engineering discipline; advanced education or qualifications in Quality Management, Regulatory Affairs, Pharmaceutical Sciences, or a related field preferred.
• Master’s degree or Ph.D. in Science or Engineering is advantageous.
• Approximately 15 years of progressive experience in Technical Operations, Manufacturing, Quality Assurance, Quality Control, or related functions within the pharmaceutical, biotechnology, medical device, or broader life sciences industry.
• At least 10 years of experience in Quality Assurance leadership roles, ideally within a GMP manufacturing environment supporting complex biologics, cell and gene therapies, advanced therapies, or other highly regulated products.
• Proven experience authoring, reviewing, and approving CMC sections of IND, BLA, or comparable regulatory submissions.
• Experience preparing regulatory responses and managing commitments arising from health authority interactions.
• Demonstrated expertise maintaining and improving electronic, workflow-enabled Quality Management Systems in accordance with current GMP and GDP requirements.
• Extensive experience leading health authority inspections, customer audits, internal audits, and external audits.
• Strong understanding of manufacturing processes, technical transfers, analytical methods, laboratory operations, and product release activities.
• Working knowledge of general chemistry, microbiology, and applicable laboratory practices.

Core Technical Knowledge

• In-depth knowledge of international GxP requirements and applicable regulatory standards, including:
  • U.S. GMP requirements under 21 CFR Parts 210, 211, 610, and, where applicable, 820
  • EU GMP requirements
  • Advanced therapy medicinal product expectations
  • ICH guidelines
  • Relevant ISO standards
  • USP, Ph. Eur., JP, and other applicable pharmacopoeial requirements
• Strong understanding of quality risk management, investigation, CAPA, change control, validation, data integrity, and inspection readiness principles.
• Ability to evaluate complex technical and operational issues and translate regulatory expectations into practical, sustainable quality systems.

Leadership Profile
The ideal candidate will bring:

• A strategic mindset combined with the ability to operate effectively at the site level.
• A track record of building strong, accountable, and collaborative Quality teams.
• Excellent verbal and written communication skills across all levels of an organization.
• The ability to influence without authority and work effectively across functions, sites, customers, and regulatory stakeholders.
• Strong judgment, structured problem-solving skills, and a risk-based approach to decision-making.
• The ability to translate strategy into measurable action in a dynamic and sometimes ambiguous environment.
• A customer-focused mindset and a demonstrated history of improving service quality, responsiveness, and stakeholder satisfaction.
• The credibility and composure to represent the organization during high-visibility inspections, audits, and partner engagements.

Why Join Us?
Working with us means joining a passionate, innovative team dedicated to making a difference in biotechnology. You’ll gain exposure to industry best practices while supporting advanced QC activities with real-world impact. Ready for your next challenge? Apply now to help shape the future of biotech!
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