Manager, QC Instrumentation Team Lead
Core
Manage and provide technical support for QC instrumentation teams to ensure analytical equipment is qualified, calibrated, and compliant with GMP regulations in a biopharmaceutical setting.
Role type
Manager, QC Instrumentation Team Lead
Builds
Qualified and calibrated analytical instrumentation for QC laboratories
Domain
Biopharmaceuticals / Quality Control / Instrumentation
Required skills
GMP compliance, instrumentation management, project management, regulatory inspection experience, team leadership, budget management, troubleshooting, change control, lifecycle management
Preferred skills
People management, regulatory inspection experience
Technologies
Analytical instrumentation, electronic laboratory systems
Responsibilities
Ensure all instruments are available, calibrated, and qualified; manage projects for new equipment installation and qualification; generate and approve qualification and calibration documentation; lead change controls and investigations; maintain GMP compliance; manage laboratory instrumentation lifecycle programmes; maintain safe working environments; participate in regulatory inspections; troubleshoot complex analytical issues; assess instrument capability for new products; lead operational excellence initiatives; provide strategic planning and direct laboratory personnel; write performance evaluations and coach staff.
Seniority
Manager, people management & technical leadership