Director, Inspection Readiness

Bristol Myers Squibb

Devens, MA, US
Base: $187,700 - $243,368 depending on location; b...
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10+ years regulatory compliance experience
Health authority inspection support (fda/ema)
Global gxp standards knowledge
** Bristol Myers Squibb is looking for a Director of Inspection Readiness to ensure the organization’s preparedness for regulatory inspections across various operations. The role demands extensive experience in regulatory compliance and quality assurance within the pharmaceutical industry, along with strong leadership and analytical skills. **

Job Summary

  • This role is responsible for driving a Global Quality inspection readiness strategy to ensure an 'always-ready' state of compliance across pharmaceutical and biologics operations.
  • The incumbent will serve as a subject matter expert supporting health authority inspections, conducting mock inspections, and analyzing regulatory observations to prevent repeat issues.
  • Bristol Myers Squibb offers competitive benefits including flexible time off, comprehensive health coverage, and a culture focused on transforming patients' lives through science.

Matching Summary

Match Score: 75

** Bristol Myers Squibb is looking for a Director of Inspection Readiness to ensure the organization’s preparedness for regulatory inspections across various operations. The role demands extensive experience in regulatory compliance and quality assurance within the pharmaceutical industry, along with strong leadership and analytical skills. **

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 included.

Skills & Requirements

Must-have

  • 10+ years regulatory compliance experience
  • Health Authority inspection support (FDA/EMA)
  • Global GxP standards knowledge
  • Mock inspections and gap analysis execution
  • Cross-functional stakeholder collaboration

Nice-to-have

  • Prior Health Authority inspector experience
  • Predictive Quality insights application
  • Thought leadership in inspection readiness
  • Enterprise-level compliance systems expertise

Key Requirements

  • Bachelor's degree in Natural Science or Pharmacy
  • 10+ years progressive experience in QA/QC and regulatory compliance
  • Experience leading internal audits of manufacturing sites
  • Demonstrated ability to manage multiple complex projects simultaneously

Work Rights

Not specified

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