Sr. Director, GMP Quality Assurance

The Sr. Director, GMP Quality Assurance will provide leadership, direction, and Quality Assurance (QA) oversight of contract manufacturers (CMOs) and service providers for cell bank, drug substance (DS), drug product (DP), packaging and labeling, and distribution of multiple products. The Sr. Director, GMP Quality Assurance will collaborate closely with CMC, Quality Compliance and Analytical Development colleagues to ensure compliance with all relevant cGMP regulations and guidelines as they pertain to manufacturing and supply operations. This individual will provide QA expertise and guidance in support of the development and product quality strategy for CMC teams and is responsible for execution of the day-to-day quality activities of CMO manufacturing, including but not limited to, disposition of all materials, deviation resolution, CAPA(s), change control(s), expiry/retest extension, product complaints and overall documentation supporting the suitability of batches. This individual is also responsible for ensuring staff execute within the Jade’s Quality Management System and adhere to policies and procedures. This role reports to the Executive Director of Quality and Compliance.