Jade Biosciences

This role provides 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 collaborates 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, and ensures staff execute within the company’s Quality Management System.

Lead the development, implementation and management of external and internal GxP (GLP, GCP and GMP) audits. Responsible for all aspects of the audit lifecycle from development of Jade’s risk-based annual audit plan to monitoring and presentation of the performance and maturity of the audit program. Support due diligence supplier assessments and continuous monitoring of supplier inspection performance.