Company Overview:
Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types.
Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology & oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. For more information, please visit www.primemedicine.com .
Department: Quality Assurance
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.
Key Responsibilities
Software Assurance, Data Integrity, and AI Credibility
Lead risk-based Quality oversight for GxP computerized systems, laboratory instruments and associated software, SaaS and other vendor-hosted systems, and AI-enabled tools.
Draft, execute, and review software assurance and qualification plans, protocols, test scripts, reports, and other controlled records using approved requirements, intended-use documentation, risk assessments, and acceptance criteria.
Evaluate software that is embedded in or controls laboratory equipment, including system interfaces, audit trails, access controls, data flows, electronic records, and the relationship between vendor evidence and Prime's qualification requirements.
Assess data-integrity risks and controls, including completeness, accuracy, consistency, traceability, security, retention, and review of data throughout the system lifecycle, and operational controls such as backup and restore, data migration, electronic signatures and periodic user-access reviews.
Conduct AI credibility assessments in accordance with established procedures and support the controlled adoption, monitoring, and lifecycle management of AI-enabled tools used across the Quality system.
Software Vendors, Implementations, and Upgrades
Conduct and document risk-based assessments of software vendors, SaaS providers, laboratory-instrument software providers, and other external service providers.
Collect and critically review vendor questionnaires, certifications, audit materials, quality agreements, validation or assurance packages, release information, and other supporting evidence; identify what additional evidence or testing Prime…