Manager, Quality Control

Role: Manager of Quality Control leading analytical laboratory operations within a GMP-regulated biopharma environment. Objectives: ensure raw materials, in-process, and finished product testing meet quality and regulatory standards, while driving efficiency and continuous improvement. Responsibilities: manage daily workflows applying Lean principles (5S, Visual Management), oversee instrumentation (chromatography systems, spectrophotometers, TOC analyzers), review complex analytical data, lead investigations (OOS/OOT), author SOPs and validation protocols, manage deviations and CAPAs, and support audits. Also responsible for method development, validation, transfer, and optimization to enhance robustness and reduce waste. Qualifications: Bachelor’s in Chemistry, Biochemistry, or related; 7+ years GMP analytical QC experience; 3+ years supervisory/managerial experience; strong expertise in analytical methods, chromatography data systems, and investigations. Preferred: advanced degrees (Master’s/PhD), extensive CDS system expertise, Lean transformation experience, and familiarity with regulatory inspections. High-Value: GMP QC testing, analytical chemistry, chromatography, data integrity, investigations, Lean methodologies, and cross-functional collaboration. Work setup: Not specified; likely on-site or hybrid given laboratory operations.