Job Description
A critical role within the Quality Assurance organisation, the Drug Substance Manufacture Associate Director will lead the QA team. Responsible for ensuring that biologic drug substance manufacturing is performed in compliance to cGMP, site SOPs and controlled documents from end-to-end, covering warehouse and supply chain management operations, manufacturing operations, batch certification by QP, batch release and shipment for biologics drug substance.
This position will be responsible for 24/7 oversight of Warehouse and Supply Chain Management (SCM), Drug Substance Manufacturing Operations and the QA team responsible for batch disposition operations.