Sr. Director, Quality Systems & Compliance

Bristol Myers Squibb

Bothell, Washington, United States
Base: $235,080 - $284,867; bonus/equity: + incenti...
50% onsite
Cgmp compliance for pharmaceuticals
Health authority inspection management
Deviation capa change control oversight
This role leads the Quality Systems and Compliance teams at the BMS Bothell Manufacturing Plant to ensure site-level cGMP compliance and effectiveness

Job Summary

  • This role leads the Quality Systems and Compliance teams at the BMS Bothell Manufacturing Plant to ensure site-level cGMP compliance and effectiveness.
  • The position is responsible for managing health authority surveillance and pre-licensure inspections while ensuring the site remains always inspection ready.
  • Bristol Myers Squibb offers a competitive salary range of $235,080 - $284,867 along with comprehensive benefits including medical, dental, vision, and 401(k) plans.

Matching Summary

Match Score: 75

This role leads the Quality Systems and Compliance teams at the BMS Bothell Manufacturing Plant to ensure site-level cGMP compliance and effectiveness.

Salary

Base: $235,080 - $284,867; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Medical, pharmacy, dental, vision, 401(k), paid time off

Skills & Requirements

Must-have

  • cGMP compliance for pharmaceuticals
  • Health Authority inspection management
  • Deviation CAPA Change Control oversight
  • Data Integrity program leadership
  • Cell Therapy industry experience
  • Root cause analysis facilitation

Nice-to-have

  • Six Sigma Lean methodology knowledge
  • Cross-functional team collaboration
  • Global quality systems alignment
  • Proactive continuous improvement mindset
  • Advanced statistical electronic tools

Key Requirements

  • Bachelor's degree in science discipline
  • 12+ years experience in Cell Therapy or pharmaceutical industry
  • Experience interfacing with FDA EMA and PMDA
  • Proven experience leading Quality professionals
  • Knowledge of ICH Q10 ICH Q9 and 21CFR Part 11

Work Rights

Not specified

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