Director, Capa Strategy, Insights & Risk Management

Bristol Myers Squibb

Devens, MA, US
Base: $187,700 - $243,368; bonus/equity: + incenti...
50% onsite
Global capa strategy and governance
Risk-based capa strategy
Capa lifecycle management
The Director will lead a global end-to-end CAPA operating model across R&D, driving strategic oversight and ensuring timely resolution of quality issues

Job Summary

  • The Director will lead a global end-to-end CAPA operating model across R&D, driving strategic oversight and ensuring timely resolution of quality issues.
  • This role will leverage data-driven insights to identify systemic risks, develop predictive risk management strategies, and strengthen inspection readiness across the enterprise.
  • 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 Director will lead a global end-to-end CAPA operating model across R&D, driving strategic oversight and ensuring timely resolution of quality issues.

Salary

Base: $187,700 - $243,368; Bonus/Equity: Additional incentive cash and stock opportunities; Benefits: Health Coverage, Wellbeing Support, Financial Well-being and Protection, Work-life benefits

Skills & Requirements

Must-have

  • Global CAPA strategy and governance
  • Risk-based CAPA strategy
  • CAPA lifecycle management
  • ICH E6(R3)/E8(R1) alignment
  • Predictive risk management strategies
  • Serious Breach Review Committee operational lead

Nice-to-have

  • Digital Transformation and Innovation
  • Foster a culture of quality
  • External partnerships and benchmarking
  • Continuous improvement initiatives

Key Requirements

  • Minimum 10+ years GxP CAPA Management experience
  • B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field
  • Applied knowledge of ICH/GCP, regulatory guidelines
  • Extensive experience in CAPA Management and Serious Breach reporting
  • Very experienced in Nonclinical, Clinical and Pharmacovigilance processes

Work Rights

Not specified

Tailored Resume

Cover Letter