Director, Capa Strategy, Insights & Risk Management

Bristol Myers Squibb

Devens, MA, US
Base: $187,700 - $243,368 depending on location; b...
50% onsite
10+ years gxp capa management experience
Expertise in ich e6(r3) and e8(r1) regulations
Root cause analysis and systemic risk detection
This role leads a global end-to-end CAPA operating model across Research & Development to ensure timely resolution of quality issues

Job Summary

  • This role leads a global end-to-end CAPA operating model across Research & Development to ensure timely resolution of quality issues.
  • The position leverages data-driven insights and advanced analytics to identify systemic risks and drive proactive quality interventions aligned with ICH guidelines.
  • Bristol Myers Squibb offers competitive benefits including flexible time off, comprehensive health coverage, and a supportive culture focused on transforming patients' lives.

Matching Summary

This role leads a global end-to-end CAPA operating model across Research & Development to ensure timely resolution of quality issues.

Salary

Base: $187,700 - $243,368 depending on location; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Medical, dental, vision, 401(k), paid time off, and wellbeing programs

Skills & Requirements

Must-have

  • 10+ years GxP CAPA Management experience
  • Expertise in ICH E6(R3) and E8(R1) regulations
  • Root cause analysis and systemic risk detection
  • Cross-functional team leadership in R&D
  • Digital transformation and predictive analytics

Nice-to-have

  • Experience with AI-driven signal detection
  • Knowledge of BMS therapeutic areas ICN and HOCT
  • Strong presentation skills for senior management
  • Culture of continuous improvement advocacy
  • Strategic partnership development with industry bodies

Key Requirements

  • Minimum 10+ years of GxP CAPA Management experience
  • B.S. or M.S. in Chemistry, Biology, Health, or Quality field
  • Subject matter expertise in Drug Development standards and regulations
  • Proven track record leading cross-functional teams
  • Extensive experience in Serious Breach reporting requirements

Work Rights

Not specified

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