Director, Quality Operations

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.

This is a full-time hybrid position based in our Somerville, Massachusetts (Assembly Row) office, with an onsite presence required three days per week. Candidates must reside within a commutable distance of the office to be considered.

The Senior Director, Quality Operations is a senior quality leader responsible for providing strategic and operational leadership for commercial Quality Operations, including external manufacturing and testing oversight, lot disposition, quality governance, and patient-specific product controls across clinical and commercial-stage supply. This role is critical in a virtual operating model and ensures that all Contract Development and Manufacturing Organizations (CDMOs), testing laboratories, and other GxP service providers operate in full compliance with global regulatory requirements and company quality standards.

This role partners closely with Manufacturing, Technical Operations, Supply Chain, Regulatory Affairs, Medical, Patient Operations, and Commercial teams to ensure uninterrupted and compliant patient supply, timely quality decisions, and sustained inspection readiness as the organization scales.

RESPONSIBILITIE****S

External Manufacturing Quality Oversight

• Provide end-to-end quality oversight of external manufacturers (CDMOs) supporting clinical and commercial cell and gene therapy products.
• Establish and maintain CDMO quality agreements, ensuring clear delineation of responsibilities for commercial operations.
• Oversee performance monitoring, periodic review, and ongoing approval of CDMOs, contract testing laboratories, logistics providers, and other critical GxP service providers.
• Establish risk-based quality scorecards and ensure significant performance or compliance concerns are escalated and remediated.
• Serve as the primary quality point of contact for assigned external partners, fostering strong, collaborative relationships.

Commercial Product Support

• Ensure compliant commercial product release, disposition, and lifecycle management, including deviations CAPAs, change controls, and investigations.