Sr. Director, Quality Systems & Compliance

Bristol Myers Squibb

Bothell, Washington, United States
Base: $235,080 - $284,867; bonus/equity: + incenti...
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Cgmp compliance expertise
Health authority inspection management
Quality systems (deviation, capa, change control)
** Bristol Myers Squibb is seeking a Sr. Director of Quality Systems & Compliance to lead and improve quality systems at their Bothell, Washington manufacturing plant. The position focuses on ensuring compliance with health authority regulations and overseeing various quality management processes. **

Job Summary

  • This role leads the Quality Systems and Compliance teams to ensure site-level cGMP compliance and effectiveness for cell therapy products.
  • 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 competitive benefits including flexible time off, comprehensive health coverage, and a supportive culture focused on transforming patients' lives.

Matching Summary

Match Score: 75

** Bristol Myers Squibb is seeking a Sr. Director of Quality Systems & Compliance to lead and improve quality systems at their Bothell, Washington manufacturing plant. The position focuses on ensuring compliance with health authority regulations and overseeing various quality management processes. **

Salary

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

Skills & Requirements

Must-have

  • cGMP compliance expertise
  • Health Authority inspection management
  • Quality Systems (Deviation, CAPA, Change Control)
  • Data Integrity program leadership
  • Cell Therapy industry experience
  • Root cause analysis facilitation

Nice-to-have

  • Six Sigma or Lean methodology knowledge
  • FMEA application skills
  • Cross-functional collaboration abilities
  • Proactive problem-solving mindset
  • Advanced communication skills

Key Requirements

  • Bachelor's degree in science discipline
  • 12+ years of experience in Cell Therapy, biotech, or pharmaceutical industry
  • Experience interfacing with FDA, EMA, and PMDA health authorities
  • Strong understanding of ICH Q10, ICH Q9, and 21CFR Part 11 regulations
  • Proven experience leading quality professionals and people leaders

Work Rights

Not specified

Tailored Resume

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