Senior Manager, Quality Control

Role: Senior Manager, Quality Control, overseeing daily laboratory operations for GMP compliance, data integrity, and testing efficiency in biopharma. Responsibilities: lead QC testing workflows applying Lean principles, monitor KPIs (Right-First-Time, TAT, OEE), manage analytical instrumentation (chromatography, spectrophotometry, TOC), author SOPs, lead investigations (OOS, OOT), ensure data integrity and audit readiness, support method development/validation, and supervise QC team. Requirements: Bachelor’s in Chemistry, Biochemistry, or related; 9+ years in GMP QC environments; 5+ years supervisory experience; expertise in analytical methods, chromatography data systems, and regulatory standards (FDA, ICH, USP); strong investigation and lean implementation skills. High-Value: GMP-regulated biopharma QC laboratory, analytical chemistry, data integrity, method validation/transfer, investigation of testing anomalies, Lean Laboratory methodologies, cross-functional collaboration, regulatory audit readiness. WorkSetup: not specified; likely on-site based on laboratory leadership role.