Commercial Quality Control Manager

Serán is expanding its Bend, Oregon campus with a new GMP manufacturing facility and is seeking an industry-experienced Commercial Quality Control Laboratory Manager to play a critical role in the facility start-up of the new QC laboratory including equipment and facility qualifications and FDA data integrity compliance. As a critical member of the Commercial Committee, the QC Commercial Laboratory Manager will be part of a cross-functional team who will plan and execute qualification projects, method transfers, validations, cleaning program, and computer system validations to support non-sterile pharmaceutical products.

Once the facility is underway, the Commercial Quality Control Manager will be responsible for leading the daily operations of the Commercial QC Laboratory in support of commercial manufacturing, raw material and 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.

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 CDMOlaboratory

• Requires 5years 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.