Sr. QA Specialist – Supplier Quality

The Sr. QA Specialist – Supplier Quality leads the qualification and ongoing quality oversight of third parties, including suppliers, service providers, and contract development and manufacturing organizations (CDMOs), while supporting key quality system functions to ensure compliance with cGMP and regulatory standards in a biotech environment. This role involves managing complex investigations, overseeing change control and CAPA processes, supporting regulatory inspections, and mentoring junior QA staff to drive continuous improvement and cross-functional collaboration. The specialist is responsible for maintaining product quality and operational excellence through rigorous quality oversight and process improvement initiatives.