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

Bristol Myers Squibb

Devens, MA, United States
Base: $100,480 - $121,756; bonus/equity: + incenti...
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Quality oversight of deviation investigations
Review and approve complex investigations
Ensure robust corrective/preventive actions
** Bristol Myers Squibb is seeking a Manager of Quality Assurance Investigations for their Cell Therapy facility in Devens, MA. The role involves overseeing quality assurance for deviation investigations in compliance with regulations and company policies. **

Job Summary

  • The Manager, Quality Assurance Investigations is responsible for quality oversight and approval of Deviation investigations and associated Action and Effectiveness Check records at the Devens Cell Therapy Facility.
  • Key responsibilities include reviewing and approving complex investigations, authoring technical reports, and ensuring corrective/preventive actions adequately address root causes.
  • The role requires a Bachelor's degree in STEM preferred, 6+ years of experience in a regulated industry with 2+ years of deviation experience, and proficiency in root cause analysis tools.

Matching Summary

Match Score: 75

** Bristol Myers Squibb is seeking a Manager of Quality Assurance Investigations for their Cell Therapy facility in Devens, MA. The role involves overseeing quality assurance for deviation investigations in compliance with regulations and company policies. **

Salary

Base: $100,480 - $121,756; Bonus/Equity: Additional incentive cash and stock opportunities may be available; Benefits: Health Coverage, Wellbeing Support, Financial Well-being and Protection, Work-life benefits

Skills & Requirements

Must-have

  • Quality oversight of deviation investigations
  • Review and approve complex investigations
  • Ensure robust corrective/preventive actions
  • Drive deviation process deployment
  • Subject Matter Expert of root cause analysis

Nice-to-have

  • Champion for culture of quality
  • Proactively monitor metrics
  • Identify improvement opportunities
  • Support integration of newer team members

Key Requirements

  • 6+ years of experience in a regulated industry
  • 2+ years of deviation experience
  • Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred
  • Demonstrated experience with electronic systems and databases
  • Proficiency in root cause analysis tools

Work Rights

Not specified

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