Senior Specialist, Qa Operations Investigations

Bristol Myers Squibb

Leiden, Netherlands
Hybrid (50% onsite)
Review and approve capa investigations
Root cause analysis tools experience
Fda/ema regulatory compliance knowledge
Bristol Myers Squibb is seeking a Senior Specialist in QA Operations Investigations to oversee the quality review and approval process for manufacturing and laboratory investigations in Leiden, Netherlands. The ideal candidate will have at least four years of experience in a regulated industry, with specific expertise in deviation management and regulatory compliance

Job Summary

  • The role is responsible for the quality review and approval of manufacturing and laboratory investigations in accordance with global cGMP standards.
  • Candidates will ensure CAPAs are robust, address root causes effectively, and support internal and external inspections as required.
  • Bristol Myers Squibb offers a wide variety of competitive benefits and programs to help employees pursue goals both at work and in their personal lives.

Matching Summary

Match Score: 85

Bristol Myers Squibb is seeking a Senior Specialist in QA Operations Investigations to oversee the quality review and approval process for manufacturing and laboratory investigations in Leiden, Netherlands. The ideal candidate will have at least four years of experience in a regulated industry, with specific expertise in deviation management and regulatory compliance.

Skills & Requirements

Must-have

  • Review and approve CAPA investigations
  • Root cause analysis tools experience
  • FDA/EMA regulatory compliance knowledge
  • Technical writing and reporting skills
  • Cross-functional team collaboration

Nice-to-have

  • Continuous improvement project support
  • Critical thinking for innovative solutions
  • Fast-paced team environment adaptability
  • Self-motivated with strong decision making
  • Training content development capabilities

Key Requirements

  • Bachelor's degree in engineering or life science
  • 4+ years regulated industry experience
  • 1+ year deviation experience
  • Experience with electronic systems and databases
  • Proficiency in root cause analysis tools

Work Rights

Not specified

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