Senior Manager, Analytical Sciences and Technology, CVRM
Core
Establish and lead the Analytical Sciences and Technology team for a new greenfield manufacturing facility, focusing on laboratory start-up, method validation, and routine QC operations for CVRM medicines.
Role type
Senior Manager, Quality Control (Analytical Sciences)
Builds
A compliant, efficient QC organization and testing infrastructure for a new drug manufacturing plant.
Domain
Pharmaceutical manufacturing (CVRM: Cardiovascular, Renal, Metabolism)
Required skills
Analytical method validation and qualification, cGMP operations, stability program management, deviation investigation, project management, team leadership, regulatory compliance (FDA/EMA)
Preferred skills
Greenfield project experience, Medical Device Functionality testing, Physical Chemistry and Microbiological Method Lifecycle Management, Contract laboratory oversight
Technologies
Laboratory instrumentation, digital tools, real-time data analytics
Responsibilities
Establish QC methods for facility and process qualifications, manage method lifecycle and routine QC operations, author and approve technical/compliance documents, own QMS records (investigations, CAPAs), drive continuous improvement and safety culture, present to regulatory inspectors
Seniority
Senior Manager, hands-on leadership
