Minimum of six years of experience in change control within a GxP environment.
6+ years of relevant experience in a GMP environment for biologics manufacturing with demonstrated change control experience.
Strong background in quality assurance and document control in regulated manufacturing settings.
Hands-on experience managing change control processes for manufacturing products, processes, equipment, facilities, and computerized systems.
Proficiency in generating, analyzing, and trending quality system metrics to support management reviews.
Ability to facilitate cross-functional meetings and navigate complex change review discussions to reach aligned decisions.
Experience writing, revising, and implementing controlled documents such as SOPs, specifications, and methods.
Technical sciences degree (BS or BA) from a scientific or technical discipline.
Demonstrated understanding of cGMP requirements and GxP operations in biologics manufacturing.