Manager, Quality Systems

About Genetix Biotherapeutics

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 that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:

Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.

SUMMARY

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.

RESPONSIBILITIES

• Oversee intake, triage, investigation, and closure of product quality complaints. Ensure complaint investigations are thorough, scientifically sound, and completed within required timelines.
• Manage the recall initiation, assessment, communication, and documentation process 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.

QUALIFICATIONS

• Bachelor's or Master's degree in Life Sciences, Engineering, or related field.
• Minimum 5 years of experience in biotechnology, pharmaceutical, or life sciences industry.
• Experience with electronic QMS platforms (e.g., Veeva Vault).
• Strong communication, problem‑solving, and cross‑functional leadership skills.