Quality Control Lab Manager

Position Summary

The Manager, Quality Control Laboratory is responsible for leading and overseeing Quality Control laboratory operations within a regulated manufacturing environment. This role ensures laboratory activities are completed accurately, efficiently, and in compliance with cGMP, applicable regulatory requirements, USP standards, data integrity expectations, and established quality systems.

This is a hands-on leadership role requiring active oversight of laboratory operations, personnel, investigations, regulatory compliance, analytical testing, and continuous improvement initiatives.

Key Responsibilities

• Lead day-to-day Quality Control laboratory operations and laboratory personnel.
• Oversee chemical, microbiological, stability, raw material, in-process, and finished product testing, as applicable.
• Ensure testing is completed accurately and on schedule to support manufacturing and product release activities.
• Maintain compliance with cGMP requirements, applicable regulatory requirements, USP standards, data integrity requirements, and internal quality systems.
• Lead and approve OOS, OOT, deviation, atypical result, and laboratory investigations.
• Support root cause analysis, CAPA development, and timely closure of laboratory quality events.
• Review laboratory documentation, change controls, risk assessments, method validations, and quality records.
• Ensure laboratory equipment, instrumentation, and computerized systems remain qualified, calibrated, maintained, and compliant.
• Manage laboratory staffing, scheduling, workload prioritization, training, and employee development.
• Support and participate in regulatory inspections, customer audits, and internal audits.
• Monitor laboratory performance metrics and identify opportunities to improve quality, efficiency, and throughput.
• Support method transfers, method validations, analytical troubleshooting, and new product introduction activities.
• Partner cross-functionally with Quality Assurance, Operations, Maintenance, Supply Chain, and other technical teams.

Required Qualifications

Education

• Bachelor’s degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, or a related scientific discipline required.
• Master’s degree preferred.

Experience

• 5-7+ years of progressive Quality Control laboratory experience within pharmaceutical, biotechnology, medical device, OTC, or another regulated industry.
• 3-5+ years of leadership or management experience within a GMP-regulated laboratory environment.
• Experience with laboratory investigations, OOS/OOT, CAPA, method validation, and quality systems.
• Experience supporting regulatory inspections and/or customer audits.

Knowledge & Skills

• Strong knowledge of cGMP requirements, applicable regulatory requirements, USP standards, ICH guidelines, and data integrity expectations.
• Experience with chromatography systems, laboratory instrumentation, and electronic quality systems.
• Strong leadership, organization, problem-solving, and decision-making skills.
• Strong written and verbal communication skills.
• Ability to manage multiple priorities and lead teams within a fast-paced manufacturing environment.