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.