Sr. Director, Quality Operations

Genetix Biotherapeutics•Somerville, MA

19h

About The Position

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. Position Summary The Senior Director, Quality Operations is a senior quality leader responsible for providing strategic and operational oversight of all externally manufactured cell and gene therapy products 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. The role partners closely with Manufacturing, Technical Operations, Supply Chain, Regulatory Affairs, and Commercial teams to ensure uninterrupted, compliant product supply and sustained inspection readiness as the organization scales.

Requirements

Bachelor’s degree in Life Sciences, Engineering, or related discipline (advanced degree preferred).
12+ years of progressive experience in Quality Operations, External Quality, or Manufacturing within biopharmaceuticals.
Prior people leadership experience at the Director or Senior Director level.
Demonstrated experience supporting commercial-stage products and post-approval lifecycle management.
Deep knowledge of GMP regulations (FDA, EMA, ICH) applicable to biologics and advanced therapies.
Proven success working in a virtual or highly outsourced operating model.
Experience supporting global regulatory inspections.

Nice To Haves

Experience with autologous and/or allogeneic cell therapy manufacturing models.
Experience supporting BLA/MAA submissions, post-approval changes, and commercial expansions.

Responsibilities

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.
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.
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.
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.
Lead, mentor, and develop a high-performing Quality Operations team.
Act as a strategic quality advisor to senior leadership and cross-functional teams.
Support company growth through onboarding of new external partners and technologies.