Manager, Quality Assurance Operations
Position Summary & Responsibilities
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 Assurance Operations’ role is responsible for providing end-to-end quality oversight of Contract Manufacturing Organizations (CMOs) to ensure compliance with cGMP regulations, regulatory commitments, and Genetix quality standards. This role serves as a key quality partner to Manufacturing, MS&T, Quality Control, and Patient Supply. The role is expected to serve as a CMO Lead point-of-contact and primary quality interface with external partners, driving proactive risk management, and Deviation and Change Control lifecycle management. The position ensures effective quality oversight through structured governance forums, review and approval of quality systems, and continuous monitoring of performance metrics.
This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.
Responsibilities
• Provide on-call QA support for manufacturing operations, ensuring proactive identification, escalation, and mitigation of quality events and risks impacting ongoing manufacturing and product disposition
• Maintain a consistent and effective external oversight model, including leading QA-to-QA forums and guiding quality discussions in joint governance meetings with CMOs.
• Lead regular internal Deviation/Lab Investigation Management meetings, ensuring compliance, quality, and timeliness.
• Review and Approve internal and external CMO Deviations and Change Controls
• Serve as QA point-of-contact for Product Complaints, ensuring appropriate investigation, documentation, and closure.
• Perform Quality Impact Assessments for Change Contr
Key Role Competencies & Evaluation Highlights
Rigorous scientific precision, unwavering commitment to regulatory compliance, and translational drug development capability.
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