Senior Manager, Quality Control Operations, Global Analytics
Core
Senior Manager leading Quality Control operations for late-stage/commercial vaccine programs at a CDMO in Europe, ensuring analytical strategies, testing compliance, and supply continuity.
Role type
Senior Manager, Quality Control Operations
Builds
Secure and uninterrupted supply of innovative bacterial disease therapies
Domain
Biotechnology / Pharmaceutical / Vaccine Development
Required skills
cGMP compliance, CDMO/contract lab management, analytical control strategy implementation, method validation and transfer, data management systems (GDP), OOS/OOT investigation, regulatory inspection support, multi-national regulations knowledge
Preferred skills
Pneumococcal vaccine experience, process improvement and automation focus
Technologies
cGMP systems, analytical instrumentation, data management systems
Responsibilities
Implement and maintain robust QC systems (sampling, testing, documentation, release) at CDMO; Ensure on-time QC testing performance for raw materials, intermediates, and drug substance; Oversee method validation and transfer activities with contract labs; Review and approve analytical data, test reports, and CoAs; Support investigations of deviations, OOS, OOT, and customer complaints; Provide technical support for Health Authority inspections; Write and approve QC documentation for regulatory compliance
Seniority
Senior Manager, hands-on leadership
