Sr. Director, Quality Operations

The posting, as Genetix Biotherapeutics wrote it

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.
• Oversee lot disposition activities in collaboration with internal stakeholders, ensuring timely and compliant decision-making.
• Provide independent Quality oversight and make or escalate timely decisions regarding product quality, patient impact, lot disposition

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tory inspections.

Preferred Qualifications

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

Key Competencies

• Strategic thinking with strong operational execution
• Strong decision-making and risk-based quality mindset
• Ability to influence and lead without direct authority
• Excellent communication and executive presence
• Comfortable operating in fast-paced, evolving environments

Additional Information

The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.

Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement & loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.

Pay Transparency
$250,000 — $302,000 USD

Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.