Senior Director, Quality Operations

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.

Our 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.

• 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.

• Ensure compliant commercial product release, disposition, and lifecycle management, including deviations CAPAs, change controls, and investigations.
• Oversee lot disposition activities in collaboration with internal stakeholders, ensuring timely and compliant decision-making.
• Provide independent Quality oversight and make or elevate timely decisions regarding product quality, patient impact, lot disposition, and regulatory compliance.
• Ensure robust controls for chain of identity, chain of custody, patient-specific labeling, product traceability, sample management, and temperature-controlled transportation.
• Support the Annual Product Quality Reviews/Product Quality Reviews and product-quality trending for assigned products and external manufacturing sites.
• Support process validation, continued process verification (CPV), comparability assessments, and post-approval changes.

• Lead external quality readiness for FDA inspections, including PAIs and commercial inspections.
• Participate directly in regulatory inspections and audits as a company representative.
• Ensure timely and effective resolution of inspection findings, observations, and commitments.
• Partner with Regulatory Affairs to support regulatory filings, post-approval changes, regulatory commitments, and assessments of potentially reportable quality events.

• Ensure effective management of CDMO audit observations, deviations, and CAPAs to closure.
• Monitor compliance trends and proactively identify and mitigate quality risks across the external network.

• Drive continuous improvement of external quality processes aligned with a virtual operating model.
• Ensure external partners comply with company Quality Management System (QMS), including documentation, training, data integrity, and change management.
• Contribute to enterprise-level quality metrics, governance forums, and management reviews.