Lead the development, implementation, and improvement of internal QC systems for internal teams and external partners. Proactively manage QC gap analyses and help lead CDMO partnerships on analytical method transfer and phase-appropriate qualification and validation. Interact across different functional groups and partner collaboratively. Manage QC quality events, such as change controls, deviations, adverse stability trends, and investigations. Oversee CDMO for analytical method transfer, reference standard generation, and stability program management. Prepare and review QC related sections of regulatory submissions.