Commercial Quality Control Manager

Supervisor 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.
• Address employee performance issues, and discipline, in accordance with company policies.
• Promote employee engagement, accountability, teamwork and continuous improvement.
• Ensure adequate staffing to support commercial manufacturing and laboratory operations.

Duties/Responsibilities

• Support qualification of new commercial lab including instrument and facility qualification.
• Collaborates with cross-functional teams to define equipment specifications, user requirements (URS), and establish project timelines and budgets.
• Develops and executes protocols for equipment IQ/OQ/PQ in alignment with site validation master plans and project timelines.
• Drive readiness activities for commercial launch supporting method qualifications, validations, GMP documentation, and tech transfer from development to commercial.
• Collaborates with multidisciplinary teams to complete change controls, deviation investigations, and CAPA’s as required.
• Collaborate with the Facilities and Maintenance teams to establish preventative maintenance schedules.
• Collaborate with IT to complete computer system validations in alignment with 21 CFR Part 11 requirements.
• Partner with Validation, QA, and Manufacturing to ensure regulatory requirements.
• Maintain inspection readiness to support internal audits, client audits, and regulatory inspections, maintaining compliance with FDA, EMA, ICH, USP, EP, and other applicable regulatory requirements.
• Lead laboratory investigations (OOS/OOT, deviations, atypical results) ensuring timely completions.
• Manage daily operations of the Commercial Quality Control laboratory.
• Support commercial batch release through timely execution of release, in-process, raw material, cleaning verification, stability testing, and documentation.
• Coordinate 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.
• Ensure laboratory documentation is accurate, complete, and compliant with ALCOA++ data integrity principles
• Oversee stability program execution including protocol implementation, sample management, testing, and reporting.

Required Skills & Abilities

• Strong working knowledge of GMP, FDA, ICH, USP, and data integrity requirements.
• Strong understanding of commercial pharmaceutical manufacturing including lab development and method transfers.
• Implementing Leand and Six Sigma methodologies to reduce waste and improve process reliability.
• Experience managing analytical testing supporting commercial product release.
• Experience leading laboratory investigations including OOS, OOT, deviations, CAPAs, and change controls.
• Strong technical knowledge of instrument qualifications for chromatographic and analytical instrumentation.
• Coordinate with vendors and contractors to ensure timely and compliant start-up of laboratory systems.
• Experience with laboratory electronic systems including LIMS, Empower, NuGenesis, or equivalent.
• Excellent scientific writing and technical documentation skills.
• Strong organizational and project management abilities.
• Communicates effectively and maintains productive relationships with coworkers, clients and other contacts outside of the company.
• Strong customer service and relationship management skills.
• Ability to manage multiple projects, create and work within internal timelines, solve problems, deliver on commitments and utilize interpersonal skills in a cross-functional team.
• Strong analytical and critical thinking skills.
• Excellent leadership, coaching, and mentoring abilities.
• Demonstrated commitment to continuous improvement and operational excellence.
• Preference for those who possess knowledge of Global Regulatory requirements (FDA/MHRA/EMEA)

Education and Experience

• Bachelor’s degreein chemistry, physics, engineering, or related scientific discipline

• Preference will be given to advanced degree holders or those with equivalent experience  

• 5-10 years of relevant experience in CDMO laboratory 

• Requires 5 years of GMP experience

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer.

• Must be able to lift up to 15 pounds at times.