Senior Specialist, Qa Operations Investigations

Bristol Myers Squibb

Leiden, Netherlands
50% onsite
Review and approve manufacturing investigations
Ensure capas address root cause
Interpret fda/ema regulations
The role is responsible for the quality review and approval of manufacturing and laboratory investigations at the CTF in Leiden

Job Summary

  • The role is responsible for the quality review and approval of manufacturing and laboratory investigations at the CTF in Leiden.
  • Candidates must ensure that Corrective and Preventive Actions (CAPAs) are robust and adequately address the root cause of quality events.
  • Bristol Myers Squibb offers a wide variety of competitive benefits, services, and programs to support employees' goals both at work and in their personal lives.

Matching Summary

The role is responsible for the quality review and approval of manufacturing and laboratory investigations at the CTF in Leiden.

Skills & Requirements

Must-have

  • Review and approve manufacturing investigations
  • Ensure CAPAs address root cause
  • Interpret FDA/EMA regulations
  • Conduct root cause analysis tools
  • Support internal and external inspections

Nice-to-have

  • Experience in cell therapy manufacturing
  • Ability to work in fast-paced environment
  • Strong verbal and technical writing skills
  • Self-motivated with critical thinking abilities
  • Build strong relationships with partner functions

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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