Associate Director, Quality Control - Technical Services

Vertex Pharmaceuticals · Boston, MA

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QualityFull-time$159k–$238kCompany career page

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Role summary

Associate Director leading technical services for GMP release and stability testing at external laboratories supporting Vertex's commercial small molecule programs. Manages contract testing relationships, ensures compliance with quality standards, oversees quality event management, and drives continuous improvement across QC operations.

What they're looking for

Master's degree with 8+ years OR Bachelor's with 10+ years pharma/biotech experience plus 6 years management
Analytical leadership experience in cGMP testing laboratories with small molecules
Proven track record building and developing high-performing teams
Technical expertise in analytical chemistry methods (LC/GC, dissolution, Karl Fischer, FTIR, XRPD)
Deep knowledge of regulatory requirements (ICH, CFR, FDA) for small molecule manufacturing
Audit and inspection interaction experience with health authorities
Ability to travel nationally and internationally up to 20%

What you'll be doing

Provide strategic and operational oversight of GMP release and stability testing at external contract laboratories
Oversee external data review processes and manage out-of-specification, out-of-trend, and adverse performance investigations
Lead quality event management including change controls, deviations, and corrective action plans with timely escalation
Monitor contract testing laboratory performance metrics and ensure compliance with SOPs and quality agreements
Drive cross-functional collaboration with manufacturing, supply management, regulatory affairs, and quality assurance teams

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