Manager, Quality Systems

At Genetix Biotherapeutics, every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role—you become part of a company pursuing curative gene therapies to give patients and families more days. We are doers, thinkers, and collaborators who embrace and live by our values.

The Manager, Quality Systems is responsible for overseeing key elements of the Quality Management System (QMS) that support manufacture and release of gene therapy products. This role manages the end-to-end complaint and recall programs, ensures accurate and timely quality metrics reporting, drives closure of open quality system records, and supports continuous improvement initiatives and SOP lifecycle management. This is a full‑time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

• Oversee intake, triage, investigation, and closure of product quality complaints, ensuring investigations are thorough, scientifically sound, and completed within required timelines.
• Manage recall initiation, assessment, communication, and documentation in compliance with regulatory expectations; maintain recall readiness, including procedures, training, and mock recall exercises.
• Lead collection, analysis, and reporting of quality metrics (e.g., complaint cycle time, deviation aging, CAPA effectiveness).
• Lead routine cross‑functional meetings to review and drive timely closure of deviations, CAPAs, change controls, complaints, and other QMS records; track action items, assign ownership, and ensure adherence to deadlines.
• Serve as the QA reviewer/approver of internal quality system records.
• Lead and support SOP revisions ensuring clarity, compliance, and alignment with business processes.
• Facilitate cross‑functional reviews, training, and implementation of updated procedures.
• Support quality improvement initiatives that enhance QMS performance, efficiency, compliance, and data integrity.
• Support internal audits and inspections.

• Bachelor’s or Master’s degree in Life Sciences, Engineering, or a related field.
• Minimum five years of experience in the biotechnology, pharmaceutical, or life sciences industry.
• Experience with electronic QMS platforms (e.g., Veeva Vault).
• Strong communication, problem‑solving, and cross‑functional leadership skills.

Base Salary Range: $117,000 – $166,000. This role is eligible for an annual bonus and long‑term incentive. Additional benefits include comprehensive health, life, and disability insurance; employer‑matched 401(k) plan; lifestyle spending account; flexible time‑off and paid holidays; tuition reimbursement and loan repayment assistance; paid parental leave; paid on‑site parking; commuter subsidy; and more.

Genetix is proud to be an equal‑opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.