Identify and manage quality risk: Proactively identify, assess, and escalate risks related to patient safety, product quality, shelf life, supply continuity, or GMP compliance; drive risk mitigation strategies in partnership with Analytical Development, Quality, and Manufacturing functions. Oversee QC operations internally and externally: Direct method validation, release and stability testing, data review, deviations, investigations, change control, and CAPA internally and at CDMOs, and CTLs.