Commercial Quality Control Manager

Duties/Responsibilities

• Recruit, interview, hire, onboard, train, and develop Quality Control laboratory personnel
• Provide daily leadership, coaching, mentoring, and technical guidance to laboratory staff
• Establish performance expectations and conduct timely performance evaluations
• Manage daily operations of the Commercial Quality Control laboratory
• Ensure timely execution of release, in-process, raw material, cleaning verification, and stability testing
• Cookordinate laboratory scheduling and prioritize testing activities to support manufacturing and customer commitments
• Monitor laboratory workload, staffing, and turnaround times to ensure on-time product disposition
• Review laboratory metrics and implement improvements to increase efficiency and effectiveness
• Avoidse ensure laboratory documentation is accurate, complete, and compliant with ALCOA++ data integrity principles
• Lead laboratory investigations (OOS/OOT, deviations, atypical results) ensuring timely completions
• Support internal audits, client audits, and regulatory inspections, maintaining compliance with FDA, EMA, ICH, USP, EP, and other applicable regulatory requirements
• Support commercial batch release through timely analytical testing and documentation
• Oversee stability program execution including protocol implementation, sample management, testing, and reporting

Requirements

• Strong working knowledge of cGMP, FDA, ICH, USP, and data integrity requirements
• Strong understanding of commercial pharmaceutical manufacturing
• Experience managing analytical testing supporting commercial product release
• Experience leading laboratory investigations including OOS, OOT, deviations, CAPAs, and change controls
• Strong technical knowledge of chromatographic and analytical instrumentation
• Experience with laboratory electronic systems including LIMS, Empower, NuGenesis, or equivalent
• Excellent scientific writing and technical documentation skills
• Excellent organizational and project management abilities
• Excellent verbal and written communication skills
• Strong customer service and relationship management skills
• Demonstrated ability to manage multiple priorities while meeting aggressive timelines
• Excellent analytical and critical thinking skills
• Excellent leadership, coaching, and mentoring abilities
• Demonstrated commitment to continuous improvement and operational excellence

Qualifications

• Bachelor’s degree in chemistry, physics, engineering, or related scientific discipline
• Advanced degree or equivalent experience preferred
• 5-10 years of relevant experience in laboratory
• Requires 5 years of GMP experience
• Previous management/supervisor experience in commercial Quality Control preferred
• Experience supporting FDA, client, and regulatory inspections preferred