Senior Software Quality Specialist

The role

The Senior Software Quality Specialist serves as the Quality owner for assigned GxP computerized systems, laboratory instruments, and associated software. The role ensures systems are appropriately assessed, qualified, implemented, maintained, changed, and retired in a compliant state.

What you will do

• Lead risk-based Quality oversight for GxP computerized systems, laboratory instruments, SaaS, and AI-enabled tools.
• Draft, execute, and review software assurance and qualification plans, protocols, test scripts, and reports.
• Evaluate software embedded in laboratory equipment, including interfaces, audit trails, and data flows.
• Assess data-integrity risks and controls throughout the system lifecycle.
• Conduct AI credibility assessments and support the management of AI-enabled tools.
• Conduct and document risk-based assessments of software vendors and service providers.
• Work with IT, Laboratory Operations, and vendors to execute system implementations and upgrades.
• Support integrated qualification of software-controlled laboratory equipment.
• Lead change controls, deviations, CAPAs, and other quality records.
• Participate in audits, regulatory inspections, and inspection-readiness activities.

Required qualifications

• 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.
• Hands-on responsibility for computerized systems, software assurance, or data integrity.
• Strong working knowledge of data-integrity principles, electronic records, and software lifecycle controls.
• Knowledge of 21 CFR Part 11, EU GMP Annex 11, GAMP 5, and computer software assurance guidance.
• Hands-on experience with IT or system administration activities such as system configuration and access management.
• Experience supporting or leading deviations, CAPAs, change controls, or investigations.
• Experience drafting, executing, or reviewing qualification protocols, test scripts, or vendor assessments.
• Strong technical writing, organization, critical-thinking, and cross-functional coordination skills.

Nice to have

• Experience in biotechnology, gene therapy, cell therapy, or another regulated life-sciences environment.
• Experience with SaaS or other vendor-hosted systems, laboratory-instrument software, or electronic laboratory systems.
• Experience with 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, and software qualification.

Benefits

• Medical
• Dental
• Vision
• Life insurance
• 401(k) match
• Equity programs
• Generous paid time off
• Wellness days
• Company-wide recharge breaks

About the company

Prime Medicine is a biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The company leverages its proprietary Prime Editing platform to develop differentiated, potentially curative genetic therapies.