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

Bristor Myers Squibb

Devens, MA, United States
Base: $100,480 - $121,756; bonus/equity: + incenti...
**
Quality oversight of deviation investigations
Review and approve complex investigations
Root cause analysis proficiency
** Bristol Myers Squibb is seeking a Manager for Quality Assurance Investigations at their Devens, MA facility, focusing on overseeing quality compliance and investigations in cell therapy manufacturing. The ideal candidate should possess significant experience in regulated industries, particularly in deviation management, and should be proficient in addressing complex quality issues. **

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/ CAPAs / effectiveness checks, authoring technical reports, and ensuring corrective/preventive actions adequately address root causes.
  • The role requires a Bachelor's degree in STEM preferred, with 6+ years of experience in a regulated industry, preferably with 2+ years of deviation experience and knowledge of FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.

Matching Summary

Match Score: 75

** Bristol Myers Squibb is seeking a Manager for Quality Assurance Investigations at their Devens, MA facility, focusing on overseeing quality compliance and investigations in cell therapy manufacturing. The ideal candidate should possess significant experience in regulated industries, particularly in deviation management, and should be proficient in addressing complex quality issues. **

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, Paid Time Off

Skills & Requirements

Must-have

  • Quality oversight of deviation investigations
  • Review and approve complex investigations
  • Root cause analysis proficiency
  • Compliance with regulations and policies
  • Technical writing and communication skills

Nice-to-have

  • Champion for culture of quality
  • Continuous improvement initiatives
  • Support for internal and external inspections
  • Coaching and mentoring staff

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 proficiency in root cause analysis tools
  • Bachelor's degree in STEM field preferred

Work Rights

Not specified

Tailored Resume

Cover Letter