Associate Director QA, GMP External Operations

Vertex Pharmaceuticals • Boston, MA

1d • Hybrid

About The Position

The Associate Director, Quality Assurance GMP Operations provides end-to-end QA oversight of external manufacturing operations across contract development and manufacturing organizations (CDMOs), from process development and technology transfer through manufacturing readiness, ramp-up, and routine clinical and commercial execution. The role ensures compliant and reliable operations, effective Quality risk management, and strong internal and external partnerships to support product quality and supply.

The position partners closely 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 stakeholders are key expectations.

The role provides Quality leadership and strategic direction across development, technology transfer, launch, and commercial manufacturing; establishes QA oversight models and governance; oversees QMS and GMP compliance; and provides independent Quality oversight of CDMO operations. Up to 40% travel may be required. The position is hybrid-eligible or on-site eligible: employees may work remotely up to two days per week in the hybrid designation, or work on-site five days per week with ad hoc flexibility.

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.
• Up to 40% travel may be required.

Nice To Haves

• Master's degree preferred.
• QA operational experience in autologous cell therapy preferred.
• Curiosity about advances in AI, technology, automation, and industry trends, and thoughtful adoption of new capabilities 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 affecting 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).
• Other benefits and resources supporting employees' career, financial, family, and wellbeing needs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior