Associate Director QA, GMP External Operations
About The Position
The Associate Director, Quality Assurance GMP Operations provides end-to-end QA oversight of external manufacturing operations across CDMOs, from process development and technology transfer through manufacturing readiness, ramp-up, and routine clinical and commercial execution. The role supports compliant and reliable operations, effective Quality risk management, and strong internal and external partnerships to support product quality and supply. The position partners with internal technical, manufacturing, supply chain, regulatory, and Quality functions, as well as external CDMO Quality and Operations teams. It establishes robust and sustainable operations, enables successful transfer and scale-up, resolves operational Quality issues, and maintains compliance throughout the product lifecycle. Close collaboration and relationship-building with internal and external stakeholders are expected to advance quality outcomes and operational excellence. The role provides Quality leadership and strategic direction; establishes QA oversight models, governance, escalation pathways, and performance expectations; and identifies and mitigates Quality and operational risks. It oversees manufacturing operations and product disposition, QMS processes, compliance performance, and CDMO operations, while supporting audit and regulatory inspection readiness. The role may require up to 40% travel and is eligible for hybrid work up to two remote days per week or on-site work five days per week, subject to company policy.
Requirements
- Bachelor's degree or relevant comparable background.
- At least 8 years of experience and at least 5 years in a management or supervisory role, or an equivalent combination of education and experience in a regulated pharmaceutical environment.
- In-depth knowledge of global GMP regulatory requirements for Cell & Gene Therapy and/or Biologics, including EU GMPs and FDA requirements.
- Strong knowledge of QA operations and external manufacturing across development, technology transfer, launch, and commercial manufacturing.
- Broad technical knowledge of cell therapy processing, aseptic manufacturing, analytical testing, and fill/finish.
- Demonstrated capability in strategic planning, risk management, root cause analysis, data analytics, and operational excellence.
- Strong critical-thinking, problem-solving, and risk-based decision-making skills.
- Excellent communication and influencing skills, including the ability to build effective internal and external partnerships and promote a strong Quality culture.
- Ability to travel up to 40% may be required.
Nice To Haves
- Master's degree preferred.
- QA operational experience in autologous cell therapy preferred.
- Curiosity and thoughtful adoption of advances in AI, technology, and automation to improve decision-making, innovation, efficiency, and patient outcomes.
Responsibilities
- Provide Quality leadership and strategic direction across development, technology transfer, launch, and commercial manufacturing.
- Establish the QA oversight model, governance, escalation pathways, and performance expectations.
- Identify and mitigate key Quality and operational risks.
- Advance digitization and technology-enabled solutions to improve QA oversight, efficiency, and decision-making.
- Provide end-to-end QA oversight from process development and technology transfer through baseline operations, ramp-up, and routine manufacturing execution.
- Ensure manufacturing and product disposition activities meet regulatory and GMP requirements.
- Provide Quality leadership for operational issues impacting manufacturing, product quality, or supply.
- Partner cross-functionally to enable compliant and reliable execution.
- Ensure compliance with applicable GMP requirements, regulatory commitments, and the Quality Management System.
- Oversee deviations, investigations, CAPAs, change controls, and Quality risk assessments.
- Monitor Quality and compliance performance and emerging risks.
- Maintain audit and regulatory inspection readiness.
- Provide independent Quality oversight and governance of CDMO manufacturing operations.
- Assess Quality readiness during technology transfer, start-up, ramp-up, and routine manufacturing.
- Monitor CDMO Quality performance and ensure timely escalation and resolution of significant issues.
- Build effective CDMO partnerships while maintaining clear Quality accountability.
Benefits
- Annual bonus and annual equity awards.
- Medical, dental, and vision benefits.
- Generous paid time off, including a week-long company shutdown in the summer and winter.
- Educational assistance programs, including student loan repayment.
- Commuting subsidy.
- Matching charitable donations.
- 401(k).
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What This Job Offers
Job Type
Full-time
Career Level
Senior
