Associate Director Quality Assurance Third Party Quality Management - Hybrid

Role: Senior Quality Assurance Lead overseeing external GMP contractors supporting clinical supplies in the Finished Goods Platform. Objectives include ensuring regulatory compliance, data integrity, and product quality for investigational and clinical trial materials. Responsibilities encompass managing vendor quality oversight, leading investigations into complex quality events, reviewing deviations, CAPAs, change controls, and conducting audits as SME. Collaborates extensively with external contractors, R&D, and Commercial teams to develop quality metrics, strategic quality initiatives, and ensure reliable supply chain performance. Qualifications: Bachelor's in Pharmacy, Biology, Chemistry, or Engineering; 8+ years (with advanced degrees requiring 8+ years) in pharma, with substantial experience in GMP, clinical packaging, labeling, distribution, and dispositioning. Preferred skills include leadership, cross-functional collaboration, strong regulatory knowledge, and expertise in GxP, audits, and quality systems. High-Value: Focus on clinical GMP, vendor oversight, investigational products, data integrity, quality investigations, and strategic quality management. Work setup: Hybrid with 25% travel; reports to QA leadership.