QA Sr. Manager

The Senior Manager of Quality Assurance at Amgen leads the QA department and plays a crucial role in establishing, implementing, and maintaining the Quality Management System. They ensure the organization's compliance with regulatory standards and drive continuous improvement initiatives.



【Responsibilities】:

• Lead the QA department and play a crucial role in establishing, implementing, and maintaining Quality Management System.

• Establish drug GQP and QMS operating policies and organizational structure per Amgen GxP, Policies and Procedures, and government regulations- products may include sterile injectable monoclonal antibodies and proteins in vials, syringes and devices and small molecules in solid oral dosage form.

• Accountable for compliance with Amgen GxP, Policies and Procedures, and government regulations

• Confirm products to be dispositioned conform to applicable requirements including GQP ordinance requirements and pe...