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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.
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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
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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.
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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