Senior Software Quality Specialist

The posting, as Prime Medicine wrote it

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 b

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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.

The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus) and an annual long-term incentive award (e.g., equity).

Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits—including medical, dental, vision, life insurance, a 401(k) match, and equity programs—along with generous paid time off, wellness days, and company-wide recharge breaks.

Our commitment to employee well-being reflects our belief that when we care for our people, we strengthen our ability to put patients first and make meaningful impact together.

U.S. Pay Range
$111,000 — $123,000 USD

Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.