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

Bristol Myers Squibb UK

Devens, MA, United States
Base: $100,480 - $121,756; bonus/equity: not speci...
On-site
Quality assurance
Deviation investigations
Capa management
Bristol Myers Squibb is seeking a Manager of Quality Assurance Investigations for its Cell Therapy facility in Devens, MA. The role involves overseeing quality assurance processes, managing deviation investigations, and ensuring compliance with regulations in a dynamic and impactful environment. ###

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 or equivalent experience, with 6+ years in a regulated industry, preferably with 2+ years of deviation experience in biopharmaceuticals or cell therapy manufacturing.

Matching Summary

Match Score: 85

Bristol Myers Squibb is seeking a Manager of Quality Assurance Investigations for its Cell Therapy facility in Devens, MA. The role involves overseeing quality assurance processes, managing deviation investigations, and ensuring compliance with regulations in a dynamic and impactful environment. ###

Salary

Base: $100,480 - $121,756; Bonus/Equity: Not specified; Benefits: Health Coverage, Wellbeing Support, Financial Well-being and Protection, Paid Time Off

Skills & Requirements

Must-have

  • Quality Assurance
  • Deviation investigations
  • CAPA management
  • Root cause analysis
  • Regulatory compliance
  • Technical writing

Nice-to-have

  • Culture of quality
  • Continuous improvement
  • Cross-functional collaboration
  • Mentoring and coaching

Key Requirements

  • 6+ years of experience in a regulated industry
  • 2+ years of deviation experience
  • Experience in FDA/EMA regulations
  • Proficiency in root cause analysis tools
  • Bachelor's degree in STEM preferred

Work Rights

Not specified

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