Sr Manager, Quality Control Technical Services
Core
Lead and provide end-to-end accountability for QC Technical Services functional areas including investigations, trending, shared services, IT support, NPI, and capital projects to ensure compliant laboratory operations and continuity of supply.
Role type
Senior Manager, Quality Control Technical Services
Builds
Compliant laboratory operations, investigation reports, trend reports, validated methods, and qualified equipment
Domain
Pharmaceutical/Biotechnology Quality Control
Required skills
cGMP compliance, laboratory investigations, CAPA management, statistical trending, sample management, computerized system validation, NPI coordination, method transfer/verification, capital project management, team leadership
Preferred skills
Advanced degree in scientific/technical discipline, experience with LIMS/Empower/Power BI, bilingual English/Spanish
Technologies
LIMS, Empower, LabX, Track Wise, SAP, Maximo, electronic validation platforms, Power BI
Responsibilities
Establish priorities and governance for QC functional areas; oversee laboratory investigations and nonconformances; direct shared services and sample management; provide business ownership for QC computerized systems; lead NPI and product lifecycle changes; execute TMT/TMV strategies; lead QC capital projects and technology initiatives; build organizational capability through coaching and succession planning.
Seniority
Senior Manager, hands-on leadership