Manager Quality Assurance Validation
Core
Lead laboratory and analytical equipment validation for a highly automated drug substance manufacturing facility, ensuring regulatory compliance and validated state for commercial and clinical operations.
Role type
Manager, Quality Assurance Validation
Builds
Validated laboratory and analytical instrumentation supporting QC and manufacturing science functions
Domain
Biopharmaceutical manufacturing / Quality Assurance
Required skills
People leadership, validation strategy design, GMP environment experience, equipment qualification (HPLC, GC, spectrophotometers), regulatory inspection defense, budget management, SOP development
Preferred skills
Highly automated or greenfield manufacturing validation experience
Technologies
HPLC, GC, spectrophotometers, balances, incubators, software-integrated analytical systems
Responsibilities
Design and develop validation policies; lead qualification strategy for laboratory instrumentation; oversee manufacturing equipment and utility validation; defend validation data during FDA inspections; manage validation budget and schedules; counsel employees and conduct hiring activities
Seniority
Manager, 7+ years experience