About this Role
Lead a QA team responsible for ensuring compliance to regulations, covering warehouse and supply chain management operations, manufacturing operations, batch certification, release, and shipment of biologics drug substance.
* Oversee the QA teams responsible for 24/7 oversight of Warehouse and Supply Chain Management (SCM), Drug Substance Manufacturing Operations, and batch disposition operations.
* Develop and implement quality systems relating to warehouse, SCM, and manufacturing and batch disposition operations.
* Review and approve SOPs, master batch records, quality risk assessments, change controls, and other documentation associated with Manufacturing, Warehouse, SCM, and batch disposition operations.
* Ensure timely and efficient disposition of biologics drug substance batches.
* Supervise direct reports on a day-to-day basis, provide training and communications, assignment, and prioritization of work.
Your Responsibilities
We are looking for a highly experienced Quality professional with:
* A degree in a technical discipline.
* At least 8 years experience in the biotechnology and/or pharmaceutical industries within a Quality role, preferably in QA or similar.
* Proven leadership skills and experience managing a QA operations team.
This is an exciting opportunity to join a dynamic and fast-paced environment and contribute to our mission - Any disease can be treated.