{"id":731736,"url":"https://alion.io/job/primemedicine-senior-quality-engineering-specialist","title":"Senior Software Quality Specialist","company":{"id":685476,"name":"Prime Medicine","domain":"primemedicine.com","url":"https://alion.io/company/primemedicine","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":null,"role_family":null,"seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Cambridge, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":111000,"max":123000,"currency":"USD","period":"year","gross":null,"usd_annual":123000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-09-07T12:30:30Z","employer_posted_date":"2026-10-29","last_verified_at":"2026-11-06T13:59:31Z","board_verified":true,"closed_at":null,"days_open":60,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":60},"description":"Company Overview:\nPrime 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. \nPrime 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.\nDepartment: Quality Assurance\nReports to: Associate Director, Informatics\nLocation: Cambridge, MA\nPosition Summary\nThe 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.\nBecause 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.\nKey Responsibilities\nSoftware Assurance, Data Integrity, and AI Credibility\nLead risk-based Quality oversight for GxP computerized systems, laboratory instruments and associated software, SaaS and other vendor-hosted systems, and AI-enabled tools.\nDraft, 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.\nEvaluate 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.\nAssess 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.\nConduct 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.\nSoftware Vendors, Implementations, and Upgrades\nConduct and document risk-based assessments of software vendors, SaaS providers, laboratory-instrument software providers, and other external service providers.\nCollect 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.\nWork with IT/Informatics, system owners, Laboratory Operations, Quality colleagues, and vendors to plan and execute system implementations, upgrades, interfaces, and remediation activities.\nDefine and maintain clear ownership, documentation, and decision records for system qualification, vendor reliance, change impact, release, periodic review, and retirement activities.\nEquipment and Laboratory Systems Interface\nSupport 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.\nPartner 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.\nReview equipment and instrument records for completeness and consistency where software, electronic records, or data flows are part of the qualification or maintenance impact assessment.\nQuality System Maintenance and Improvement\nSupport and, where assigned, lead change controls, deviations, CAPAs, and other quality records involving computerized systems, software, equipment data, vendors, or data-integrity risks.\nPerform investigations and impact assessments, define appropriate corrective or preventive actions, and track assigned actions through timely, objective closure.\nMaintain system inventories, qualification and assurance plans, vendor-assessment records, periodic-review records, trackers, dashboards, and status reports.\nAuthor and maintain procedures for computerized systems and data integrity, and train system owners on them.\nIdentify recurring issues, documentation gaps, overdue activities, and opportunities for practical process improvement; escalate compliance risks or delays promptly.\nParticipate in audits, regulatory inspections, and inspection-readiness activities as needed.\nQualifications\nBachelor's degree in a scientific, engineering, technical, or quality-related field, or equivalent relevant experience.\nAt least four years of experience in a regulated life-sciences, medical-device, pharmaceutical, or other GxP environment with hands-on responsibility for computerized systems, software assurance, data integrity, quality systems, or a related quality function.\nStrong 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.\nHands-on experience working with IT or system administration activities such as system configuration, access management, interfaces, data flows, troubleshooting, or implementation support.\nExperience supporting or leading deviations, CAPAs, change controls, investigations, or other controlled quality records involving software, computerized systems, or data.\nExperience drafting, executing, or reviewing qualification protocols, software assurance test scripts, vendor assessments, risk assessments, or other controlled quality records.\nStrong 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.\nPreferred Experience\nExperience in biotechnology, gene therapy, cell therapy, or another regulated life-sciences environment.\nExperience with SaaS or other vendor-hosted systems, laboratory-instrument software, electronic laboratory systems, computerized system implementation, or software lifecycle management.\nExperience performing AI credibility, model-risk, or other risk-based assessments of AI-enabled tools.\nFamiliarity with integrated equipment lifecycle activities, including URS, IQ/OQ/PQ, software qualification, periodic review, calibration, maintenance, and supplier or service-provider oversight.\nThe 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).\nPrime 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.\nOur 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.\nU.S. Pay Range\n$111,000—$123,000 USD\nPrime Medicine is proud to be an equal opportunity employer. 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