Remote Pharmaceuticals Jobs • Quality Assurance

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.

Serves as Global Safety Lead and the Company-wide patient safety expert for assigned pharmaceutical / biological / drug-device combined products, accountable for the safety strategy and major safety deliverables for each assigned product. Leads GPSE Safety Team and Safety Management Team for assigned compounds and products. Manages cross-functional assessment of benefit-risk profile and communication of safety information for assigned compounds and products.