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 effectively
Apply FDA/EMA regulations in biopharma
Conduct root cause analysis using 5-WHY
Support internal and external inspections
Nice-to-have
Experience with electronic system databases
Ability to present technical data clearly
Self-motivated team player
Critical thinking for innovative solutions
Cross-functional collaboration skills
Key Requirements
Bachelor's degree in engineering or life science
4+ years experience in regulated industry
1+ year deviation experience required
Demonstrated experience with root cause analysis tools