Senior Manager, QC Chemistry and Device Testing (CVRM)
Core
Establish and lead the QC Chemistry and Device Testing team for a new greenfield facility manufacturing CVRM medicines, focusing on laboratory start-up, qualification, and commercial operations.
Role type
Senior Manager, Quality Control Chemistry and Device Testing
Builds
A highly effective and engaged QC organization capable of delivering safe, compliant, and efficient testing for CVRM products.
Domain
Pharmaceutical manufacturing (CVRM: Cardiovascular, Renal, and Metabolism)
Required skills
Analytical method validation and qualification, cGMP operations, ICH guidelines, global Health Authority regulatory requirements, project management, budget management (OpEx/CapEx), team leadership and coaching, strategic project execution, audit readiness.
Preferred skills
Greenfield project experience, Medical Device Functionality testing oversight, Operational Excellence certification (Lean Six Sigma, 5S, Kaizen).
Responsibilities
Establish core QC capabilities for facility and process qualifications, author and approve critical technical and compliance documents, own QMS records including investigations and CAPAs, drive continuous improvement and safety culture, partner globally to harmonize QC standards, present QC topics during regulatory inspections.
Seniority
Senior Manager, strategic leadership and team building