Associate Director, GMP Operational Quality - Cell & Genetic Therapies Job at Vertex Pharmaceuticals, Boston, MA

  • Vertex Pharmaceuticals
  • Boston, MA

Job Description

Associate Director overseeing GMP operational quality for cell and genetic therapies at a rare disease-focused pharmaceutical company. Responsible for leading a quality team, managing compliance with regulatory requirements, and developing personnel while supporting manufacturing operations.

Responsibilities

  • Lead quality team providing oversight and support to GMP business activities
  • Oversee CMO and vendor performance including quality agreements and compliance
  • Develop and maintain compliant quality processes supporting GMP manufacturing
  • Drive continuous process improvements and lead performance tracking and reporting
  • Manage talent acquisition, performance reviews, and individual career development

Requirements

  • Bachelor's degree in scientific or allied health field
  • 8+ years work experience and 2+ years management experience
  • In-depth knowledge of cGMP principles and global GMP requirements
  • Demonstrated success building and managing high-performing teams
  • Experience leading investigations, root cause analysis, and CAPA processes
  • Proficiency with electronic document management systems (QDocs, Trackwise, Veeva)
  • Strong cross-functional communication and influence skills

Compensation: $156,600-$234,800 base

Job Tags

Work experience placement

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