Senior Manager, QC Chemistry and Device Testing (CVRM)
Core
Establish and lead the QC Chemistry and Device Testing team to deliver safe, compliant, and efficient testing for CVRM (Cardiovascular, Renal, and Metabolism) products at a new greenfield manufacturing facility.
Role type
Senior Manager, QC Chemistry and Device Testing
Builds
A highly effective and engaged QC organization capable of supporting facility, utility, and process qualifications, transitioning to routine commercial operations.
Domain
Pharmaceutical manufacturing (CVRM medicines)
Deliverable
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (specifically: establishing QC capabilities, testing, and compliance for drug products)
Required skills
cGMP operations, analytical method validation, laboratory instrumentation, project management, budget management (OpEx/CapEx), regulatory inspection readiness, QMS record ownership, Lean Leadership
Preferred skills
Greenfield project experience, Medical Device Functionality testing oversight, Operational Excellence certification (Lean Six Sigma)
Responsibilities
Champion proactive quality and safety cultures; establish KPIs for compliance and Right-First-Time execution; author and approve critical technical and compliance documents; manage QMS records including investigations and CAPAs; present QC topics during regulatory inspections; partner globally to harmonize QC standards.
Seniority
Senior Manager, hands-on leadership
