Reports to: Associate Director, Informatics
Location: Cambridge, MA
Position Summary
The Senior Software Quality Specialist serves as the Quality owner, across the lifecycle, for assigned GxP computerized systems, laboratory instruments and associated software, and the data generated, processed, or maintained by those systems. The role works closely with Quality, Laboratory Operations, IT/Informatics, system owners, equipment owners, and external vendors to ensure that systems are appropriately assessed, qualified, implemented, maintained, changed, and retired in a compliant and inspection-ready state.
Because software is frequently inherent to the equipment used in Prime's laboratories, equipment qualification often includes qualification of the instrument software, interfaces, audit trails, data flows, and associated electronic records. The Specialist applies a risk-based approach to these integrated hardware and software activities, while supporting data integrity, vendor oversight, system implementations and upgrades, and the responsible use of AI-enabled tools.