QA Investigations Senior Specialist - CAPA & Compliance

Bristol Myers Squibb; Leiden; On-site; EUR 70,000 - 110,000; Full time

Job summary

Bristol Myers Squibb in Leiden seeks a Senior Specialist, QA Operations Investigations to provide quality oversight of manufacturing and laboratory investigations at the CTF. You will review CAPAs, risk assessments, and deviation reports to ensure compliance with cGMP and regulatory requirements.

The role requires collaboration across sites, support for inspections, and leadership in training and data sharing to strengthen quality systems and continuous improvement.

Qualifications

• Bachelor's degree in engineering or life science is preferred.
• 4+ years of experience in a regulated industry with deviation experience.
• Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.

Responsibilities

• Review and approve investigations / CAPAs / effectiveness checks for the manufacturing site.
• Author, review, and approve technical reports to support the deviations program.
• Ensure CAPAs address root cause and support timely closure of quality events.
• Perform routine reporting and analysis of metrics and assist cross functional teams.
• Support inspections and training content delivery; lead cross functional meetings.

Skills

Regulatory guidelines

MS Office

Data interpretation

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in engineering or life science

4+ years regulated industry experience

Tools

Electronic systems

Databases

Root cause analysis tools

Job description

Bristol Myers Squibb in Leiden seeks a Senior Specialist, QA Operations Investigations to provide quality oversight of manufacturing and laboratory investigations at the CTF. You will review CAPAs, risk assessments, and deviation reports to ensure compliance with cGMP and regulatory requirements.

The role requires collaboration across sites, support for inspections, and leadership in training and data sharing to strengthen quality systems and continuous improvement.