Associate Director Quality Assurance Third Party Quality Management - Hybrid

Role: Senior Quality Assurance Lead overseeing external vendor and CMO GMP activities supporting clinical supply production within the Finished Goods platform. Primary objectives include ensuring regulatory compliance, data integrity, and quality of clinical supplies, while acting as the quality liaison for third-party contractors. Responsibilities encompass managing quality oversight of vendors, leading investigations of quality events, reviewing deviations, change controls, and audit responses, and developing key quality metrics. The role also involves collaborating closely with R&D, procurement, and commercial teams, and leading cross-functional projects to improve vendor quality systems. Requirements: Bachelor’s in Pharmacy, Biology, Engineering, Chemistry, or related field, with 8+ years (advanced degree with 8+ or bachelor’s with 10+ years) of relevant biopharma experience. Expertise in GMP, clinical packaging, labeling, distribution, and dispositioning, with strong knowledge of regulatory standards and quality systems. Preferred skills include leadership, strategic project management, and experience in drug development, quality disposition, and vendor oversight, especially related to Investigational Medical Products, finished goods, and GMP compliance. High-value specifics: focus on GMP oversight in R&D/clinical manufacturing, vendor quality management, and regulatory compliance in a hybrid work setting with 25% travel.