Associate Director, GMP Operational Quality (Biologics and Devices) Job at Vertex Pharmaceuticals, Boston, MA

  • Vertex Pharmaceuticals
  • Boston, MA

Job Description

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

Job Tags

Contract work

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