Commercial Quality Control Manager

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.