Manager, Quality Assurance Investigations, Cell Therapy, Devens - Ma

Bristol Myers Squibb UK

Devens, MA, US
Base: $100,480 - $121,756; bonus/equity: + incenti...
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Root cause analysis tools (5-why, fishbone)
Deviation investigation approval experience
Fda/ema regulatory compliance knowledge
** Bristol Myers Squibb is seeking a Manager for Quality Assurance Investigations in their Devens, MA facility, focusing on oversight and approval of deviation investigations and ensuring compliance with regulatory guidelines. The role emphasizes quality assurance in cell therapy manufacturing and requires strong analytical skills and team leadership capabilities. **

Job Summary

  • The role provides quality oversight and assurance of manufactured products in compliance with FDA/EMA regulations and BMS policies.
  • Candidates will be responsible for reviewing complex investigations, approving CAPAs, and ensuring corrective actions robustly address root causes.
  • Bristol Myers Squibb offers a wide variety of competitive benefits including health coverage, financial well-being programs, and flexible time off.

Matching Summary

Match Score: 75

** Bristol Myers Squibb is seeking a Manager for Quality Assurance Investigations in their Devens, MA facility, focusing on oversight and approval of deviation investigations and ensuring compliance with regulatory guidelines. The role emphasizes quality assurance in cell therapy manufacturing and requires strong analytical skills and team leadership capabilities. **

Salary

Base: $100,480 - $121,756; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Medical, dental, vision, 401(k), paid time off

Skills & Requirements

Must-have

  • Root cause analysis tools (5-WHY, Fishbone)
  • Deviation investigation approval experience
  • FDA/EMA regulatory compliance knowledge
  • CAPA effectiveness check review
  • Technical report authoring skills

Nice-to-have

  • Cell therapy manufacturing background
  • Cross-functional team leadership
  • Continuous improvement project drive
  • Strategic thinking in quality systems
  • Subject matter expertise coaching

Key Requirements

  • Bachelor's degree in STEM field preferred
  • 6+ years of regulated industry experience
  • 2+ years of deviation experience required
  • Proficiency in root cause analysis tools
  • Experience with electronic systems and databases

Work Rights

Not specified

Tailored Resume

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