Manager, Quality Assurance Shop Floor Support, Cell Therapy

Bristol Myers Squibb

Devens, MA, US
Base: $100,480 - $121,756; bonus/equity: + incenti...
50% onsite
Quality oversight of operations
Cgmp compliance
Batch record review
The Quality Assurance Shop Floor (QASF) organization is responsible for quality oversight and advising on quality operations at the Devens Cell Therapy Facility in accordance with BMS policies, standards, procedures, and Global current Good Manufacturing Practices (cGMPs)

Job Summary

  • The Quality Assurance Shop Floor (QASF) organization is responsible for quality oversight and advising on quality operations at the Devens Cell Therapy Facility in accordance with BMS policies, standards, procedures, and Global current Good Manufacturing Practices (cGMPs).
  • Key responsibilities include handling internal compliance and documentation tasks, routine communication to front-line employees, metrics/monitoring for key QASF processes, and serving as a local process owner for core QASF systems.
  • Bristol Myers Squibb offers a wide variety of competitive benefits, services and programs that provide employees with the resources to pursue their goals, both at work and in their personal lives.

Matching Summary

The Quality Assurance Shop Floor (QASF) organization is responsible for quality oversight and advising on quality operations at the Devens Cell Therapy Facility in accordance with BMS policies, standards, procedures, and Global current Good Manufacturing Practices (cGMPs).

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 operations
  • cGMP compliance
  • Batch record review
  • Deviation management
  • Change control impact assessment
  • GxP electronic systems experience

Nice-to-have

  • Psychological and physical safety champion
  • Teamwork and continuous improvement culture
  • Pioneering mindset
  • Microbial controls experience
  • Lean or Six Sigma improvements

Key Requirements

  • 6+ years of relevant cGMP experience
  • 2+ years of QA shop floor experience
  • Bachelor's degree in STEM field preferred
  • Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing preferred
  • Project management experience preferred

Work Rights

Not specified

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