Serán is seeking a Commercial Quality Control Laboratory Manager who is responsible for leading the daily operations of the Commercial Quality Control Laboratory in support of commercial manufacturing, product release, stability testing, and ongoing GMP compliance. This position ensures analytical testing is performed accurately, efficiently, and in compliance with current Good Manufacturing Practices (cGMP), ICH guidelines, FDA regulations, and company procedures.
The Commercial QC Laboratory Manager provides leadership to QC laboratory personnel, oversees laboratory scheduling and resource allocation, manages investigations, laboratory deviations, OOS/OOT events, change controls, and CAPAs, and partners closely with Manufacturing, Supply Chain, Analytical Development, and Quality Assurance to ensure timely release of commercial products.
This role is responsible for maintaining inspection readiness, driving operational excellence, developing laboratory personnel, and fostering a culture of quality, accountability, continuous improvement, and customer focus.
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
- 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
- Always maintain inspection readiness.
- 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.
Required Skills & Abilities- 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.
- Strong 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.
- Strong analytical and critical thinking skills.
- Excellent leadership, coaching, and mentoring abilities.
- Demonstrated commitment to continuous improvement and operational excellence.
Education and Experience- 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.
