Assoc Director, Quality Assurance GMP

Role: Associate Director of Quality Assurance GMP supporting GMP clinical manufacturing, product release, and analytical review in a precision oncology company. Responsibilities: oversee GMP/CMC operations, review batch records, Certificates of Analysis, and deviations; collaborate with Qualified Persons for batch certification and release; manage vendor oversight, audits, and compliance activities; support supply chain for clinical programs both domestically and internationally; develop and review quality procedures, agreements, and metrics; act as QA representative during production and audits. Requirements: BS in Biology, Chemistry, or related; 8+ years in pharmaceutical GxP environments with GMP QA experience, preferably in small molecule drug products and biologics; strong knowledge of GMP/CMC regulations, FDA interactions, and international supply; experience with electronic QMS platforms, vendor management, and regulatory inspections. Preferred: advanced degrees, Quality Systems expertise, and international regulatory experience. High-value specifics: focus on GMP pharma manufacturing, biologics and small molecules, clinical-stage (IND), with responsibilities spanning quality oversight, vendor management, and compliance within a fast-paced biotech setting. Collaboration/reporting: reports to the Executive Director, Quality Assurance GMP. Work setup: not specified, but implied involvement in manufacturing activities, potentially on-site with regulators or vendors.