Executive Director, Gmp Quality Assurance

Apogee Therapeutics

Remote, US
Base: $275,000-$305,000; bonus/equity: performance...
Remote
15+ years gmp qa experience
Clinical to commercial transition leadership
Veeva quality suite (qms) functional lead
Apogee Therapeutics is seeking an Executive Director of GMP Quality Assurance to lead the development and execution of the company's global GMP QA strategy. The ideal candidate will have extensive experience in GMP QA within the biotech or pharmaceutical sectors and possess strong leadership skills to manage the transition from clinical development to commercial readiness

Job Summary

  • The role involves serving as a senior quality leader responsible for developing and executing the global GMP QA strategy to support the company's transition from clinical development to commercial readiness.
  • Candidates must have a proven track record of leading GMP QA organizations through commercial manufacturing launch and post-approval operations while managing external manufacturing partners.
  • The position offers market competitive compensation including base salary, performance bonus, equity grants, health benefits, and three weeks of PTO.

Matching Summary

Match Score: 85

Apogee Therapeutics is seeking an Executive Director of GMP Quality Assurance to lead the development and execution of the company's global GMP QA strategy. The ideal candidate will have extensive experience in GMP QA within the biotech or pharmaceutical sectors and possess strong leadership skills to manage the transition from clinical development to commercial readiness.

Salary

Base: $275,000-$305,000; Bonus/Equity: Performance bonus and equity grant opportunities; Benefits: Health, welfare, retirement, three weeks PTO, paid sick leave

Skills & Requirements

Must-have

  • 15+ years GMP QA experience
  • Clinical to commercial transition leadership
  • Veeva Quality Suite (QMS) functional lead
  • Global GMP regulation compliance FDA EMA ICH
  • External CMO CDMO partner oversight

Nice-to-have

  • Fast-paced dynamic environment adaptability
  • C.O.R.E. values commitment Caring Original Resilient Egoless
  • Strategic vision for inspection readiness
  • Coaching and developing senior leaders

Key Requirements

  • 15+ years progressive GMP QA experience
  • Experience with Veeva Quality Suite governance
  • Direct leadership of regulatory inspections
  • Managing managers and senior professionals

Work Rights

Not specified

Tailored Resume

Cover Letter