Sr. Manager, Quality Control Labs
Core
Leading laboratory operations and quality control functions to ensure product and raw material compliance with global, local, and internal regulations.
Role type
Senior Manager, Quality Control Labs
Builds
Quality control processes and compliance for ophthalmic products
Domain
Medical device / Pharmaceutical manufacturing
Required skills
GxP regulations, Standard Operating Procedures (SOPs), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Documentation Practice (GDP), Out of Specification (OOS) investigations, Corrective and Preventive Actions (CAPA), Health Safety and Environment (HSE), budget management, team leadership, resource allocation, audit support
Preferred skills
Science or Engineering degree, Medical device or pharmaceutical industry experience
Technologies
Microbiology, Analytical Science and Technology (AS&T), Incoming Inspection, Calibration / Metrology
Responsibilities
Lead multiple teams in quality control labs to ensure product and raw material compliance; Guide and supervise team activities, make key decisions, approve projects, and allocate resources; Oversee Microbiology, AS&T, Incoming Inspection, and Calibration / Metrology; Ensure adherence to GxP regulations, SOPs, and maintain accurate documentation; Provide support for internal and external audit inspections; Develop and improve QA programs, policies, processes, procedures, and controls; Allocate resources to lead, plan, and execute project activities in alignment with site initiatives and budgetary requirements.
Seniority
Senior, hands-on IC with leadership responsibilities