Cell Therapy Investigations Manager

Bristol Myers Squibb; Leiden; Hybrid; EUR 120,000 - 180,000; Full time

Job summary

Bristol Myers Squibb Netherlands is seeking a Manager, MSAT Investigations to lead complex root-cause investigations in the Leiden Cell Therapy Manufacturing Facility. You will drive corrective actions, CAPAs, and risk assessments with cross-functional teams.

You will ensure audit readiness, support regulatory inspections, and mentor colleagues on Investigation Program fundamentals while staying current with industry standards.

Qualifications

• Experience in biopharmaceutical operations with a minimum of 5 years.
• Bachelor’s degree in science, engineering, biochemistry or related discipline.
• Proficient in quality systems and regulatory guidelines (cGMP).

Responsibilities

• Lead complex root cause investigations and CAPAs as a Senior Investigator.
• Collaborate with Process Engineering, Facilities, QA and QC for effective investigations.
• Proactively manage investigations to timely, compliant closure per KPIs.
• Present findings to site senior management and stakeholders.
• Apply Quality Risk Management and Operational Excellence to drive improvements.
• Support regulatory inspections and maintain audit readiness.
• Mentor colleagues on Investigation Program fundamentals.

Skills

Root cause analysis

Operational Excellence

Lean manufacturing

Cell therapy

cGMP compliance

Communication

Strategic thinking

Team leadership

Education

Bachelor's degree in science/engineering/biochemistry

Job description

Bristol Myers Squibb Netherlands is seeking a Manager, MSAT Investigations to lead complex root-cause investigations in the Leiden Cell Therapy Manufacturing Facility. You will drive corrective actions, CAPAs, and risk assessments with cross-functional teams.

You will ensure audit readiness, support regulatory inspections, and mentor colleagues on Investigation Program fundamentals while staying current with industry standards.