In this role, the Senior Director, Quality Assurance applies a risk-based approach to prioritize QA support for GMP operations, including review and approval of executed batch records, deviations, analytical data, stability data, change controls, CAPAs, specifications, protocols and reports, and other GMP documentation. The role partners closely with CMC, Technical Operations, Quality Control, Regulatory, Clinical Supply, and external CDMOs/contract laboratories to identify and escalate compliance risks, enable proactive decision-making, and ensure product quality, patient safety, data integrity, and supply continuity.