This position partners with Engineering, Facilities, Validation, Manufacturing, MSAT, IT, and other cross-functional teams to provide science- and risk-based Quality oversight and ensure facilities, utilities, equipment, systems, and validated processes remain compliant and in a state of control throughout their lifecycle. The Senior QA Specialist provides Quality Assurance oversight and support for Facilities, Engineering, Validation, Cleaning Validation, Metrology, computerized systems, and related GMP activities supporting clinical and commercial manufacturing operations.