Bristol Myers Squibb is seeking a Senior Manager, MSAT Investigations to lead a team providing investigations support to the Leiden Cell Therapy Manufacturing Facility. The successful candidate will establish processes for investigations, corrective and preventative actions, audit readiness, APQR, and product complaints.
Requirements
- Direct supervision of a team of lead investigators
- Establishing, maintaining, and executing the investigations, CAPA, and product complaints programs
- Performing Root Cause Analysis Investigations for complex deviations and trend deviations
- Establishing and reporting metrics for compliance activities
- Representing the Site MS&T Investigations team in cross-functional forums
- Review and approval of site and department SOPs
- Ensuring safe and compliant cGMP operations and maintaining permanent inspection readiness
- Interacting with other teams including Process Engineering, Manufacturing Operations, Quality Assurance, Supply Chain Operations, Site Engineering, and Quality Control
Benefits
- Competitive benefits
- Services and programs that provide employees with the resources to pursue their goals