Associate Director, GMP Operational Quality (Biologics and Devices)

$94.6k - $141.8k

Vertex Pharmaceuticals

Vertex Pharmaceuticals seeks an Associate Director of GMP Operational Quality to lead quality oversight across biologics and device programs. The role manages complex quality initiatives, deviation investigations, and regulatory compliance while partnering with cross-functional teams and external manufacturing partners.

Responsibilities

Lead deviation investigations, OOS/OOT events, and CAPA implementation with scientific rigor
Represent Quality on cross-functional teams and serve as senior technical decision-maker
Draft, negotiate, and oversee Quality Agreements with CDMOs and suppliers
Review and approve batch records, change controls, and complex quality investigations
Analyze quality metrics and performance trends to identify risks and drive continuous improvement

Requirements

Bachelor's degree in scientific or allied health field
8+ years GMP Quality experience with leadership of complex initiatives
Deep knowledge of cGMP principles in biologics manufacturing
Experience managing quality agreements and relationships with contract manufacturers
Proficiency with document management systems such as QDocs, TrackWise, or Veeva
Demonstrated ability to lead investigations, root cause analysis, and CAPA implementation
Strong cross-functional leadership and influence skills in matrixed environments

Compensation: $94,600 - $141,800 base

Apply

Vacancy posted 1 day ago

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