Director, Capa Strategy, Insights & Risk Management

Bristol Myers Squibb UK

Devens, MA, US
Devens - ma - us: $200,840 - $243,368; madison - g...
Hybrid (50% onsite)
Global end-to-end capa operating model
Strategic oversight of capa processes
Data-driven insights for systemic risks
Bristol Myers Squibb is seeking a Director for CAPA Strategy, Insights, and Risk Management to lead the development and oversight of global CAPA processes within its Research and Development sector. The ideal candidate will have extensive experience in quality management, regulatory compliance, and a strong ability to leverage data for continuous improvement in clinical processes

Job Summary

  • Lead a global end-to-end CAPA operating model across R&D, driving strategic oversight and ensuring timely resolution of quality issues.
  • Leverage data-driven insights to identify systemic risks, develop predictive risk management strategies, and strengthen inspection readiness.
  • Partner with key stakeholders across Research, Drug Development, and Quality functions to influence accountability and drive continuous improvement.

Matching Summary

Match Score: 85

Bristol Myers Squibb is seeking a Director for CAPA Strategy, Insights, and Risk Management to lead the development and oversight of global CAPA processes within its Research and Development sector. The ideal candidate will have extensive experience in quality management, regulatory compliance, and a strong ability to leverage data for continuous improvement in clinical processes.

Salary

Devens - MA - US: $200,840 - $243,368; Madison - Giralda - NJ - US: $187,700 - $227,445; Princeton - NJ - US: $187,700 - $227,445; 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

  • global end-to-end CAPA operating model
  • strategic oversight of CAPA processes
  • data-driven insights for systemic risks
  • predictive risk management strategies
  • ICH E6(R3)/E8(R1) compliance
  • cross-functional team leadership

Nice-to-have

  • champion digital transformation
  • foster a culture of quality
  • external partnerships and benchmarking

Key Requirements

  • Minimum 10+ years of GxP CAPA Management experience
  • BS/MS in Chemistry, Biology, Health, or Quality related field
  • Applied knowledge of ICH/GCP and regulatory guidelines
  • Extensive experience in CAPA Management and Serious Breach reporting

Work Rights

Not specified

Tailored Resume

Cover Letter