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 requires.
• Work with IT/Informatics, system owners, Laboratory Operations, Quality colleagues, and vendors to plan and execute system implementations, upgrades, interfaces, and remediation activities.
• Define and maintain clear ownership, documentation, and decision records for system qualification, vendor reliance, change impact, release, periodic review, and retirement activities.

Equipment and Laboratory Systems Interface

• Support integrated qualification of software-controlled laboratory equipment, including review of intended use, requirements, risk assessments, qualification protocols, executed records, raw data, discrepancies, and final reports.
• Partner with Laboratory Operations and equipment owners on calibration, preventive maintenance, service, and equipment-lifecycle activities when they affect software, data integrity, qualification status, or GxP use.
• Review equipment and instrument records for completeness and consistency where software, electronic records, or data flows are part of the qualification or maintenance impact assessment.

Quality System Maintenance and Improvement

• Support and, where assigned, lead change controls, deviations, CAPAs, and other quality records involving computerized systems, software, equipment data, vendors, or data-integrity risks.
• Perform investigations and impact assessments, define appropriate corrective or preventive actions, and track assigned actions through timely, objective closure.
• Maintain system inventories, qualification and assurance plans, vendor-assessment records, periodic-review records, trackers, dashboards, and status reports.
• Author and maintain procedures for computerized systems and data integrity, and train system owners on them.
• Identify recurring issues, documentation gaps, overdue activities, and opportunities for practical process improvement; escalate compliance risks or delays promptly.
• Participate in audits, regulatory inspections, and inspection-readiness activities as needed.

Qualifications

• At minimum, a bachelor’s degree in a scientific, engineering, computer science, or other technical field, or equivalent relevant experience.
• At least 5 years of experience in a regulated life-sciences, medical-device, pharmaceutical, or other GxP environment, with hands-on responsibility for computerized systems, software assurance, or data integrity.
• Strong working knowledge of data-integrity principles, electronic records, computerized systems, software lifecycle controls, risk-based qualification or assurance, including 21 CFR Part 11, EU GMP Annex 11, GAMP 5, and computer software assurance guidance.
• Hands-on experience working with IT or system administration activities such as system configuration, access management, interfaces, data flows, troubleshooting, or implementation support.
• Experience supporting or leading deviations, CAPAs, change controls, investigations, or other controlled quality records involving software, computerized systems, or data.
• Experience drafting, executing, or reviewing qualification protocols, software assurance test scripts, vendor assessments, risk assessments, or other controlled quality records.
• Strong technical writing, organization, critical-thinking, and cross-functional coordination skills, including the ability to make risk-based decisions where procedures do not prescribe every detail.

Preferred Experience

• Experience in biotechnology, gene therapy, cell therapy, or another regulated life-sciences environment.
• Experience with SaaS or other vendor-hosted systems, laboratory-instrument software, electronic laboratory systems, computerized system implementation, or software lifecycle management.
• Experience performing AI credibility, model-risk, or other risk-based assessments of AI-enabled tools.
• Familiarity with integrated equipment lifecycle activities, including URS, IQ/OQ/PQ, software qualification, periodic review, calibration, maintenance, and supplier or service-provider oversight.