Job Details

A company is looking for a Director, CMC Quality Assurance.Key ResponsibilitiesBuild and enhance the CMC quality management system, ensuring scalability through commercial launchOversee quality assurance for CDMOs and contract testing laboratories, including audits and quality agreementsLead PAI readiness activities and serve as QA lead during FDA inspections and regulatory interactionsRequired QualificationsBS, MS, or PhD in Pharmaceutical Sciences, Chemistry, Biology, or related life sciences; advanced degree preferred15+ years of experience in pharmaceutical or biotechnology quality assurance, with significant experience in senior CMC QA rolesExperience building CMC quality systems from the ground upDeep knowledge of FDA GMP regulations, ICH guidelines, and quality risk management principlesExperience with small molecule OSD and managing CDMOs from a QA perspective