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Sr. Director, Quality Operations

4 hours ago

Somerville, Massachusetts, United States Genetix Biotherapeutics Full time


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.

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.

Key Responsibilities

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.
  • 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.
  • Support process validation, continued process verification (CPV), comparability assessments, and post-approval changes.

Regulatory & Inspection Readiness

  • 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.

Audit & Compliance Leadership

  • 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.

Quality Systems & Governance

  • 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.

Leadership & Cross-Functional Partnership

  • 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.

Qualifications

Required

  • 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.

Preferred

  • 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:

Base Salary Range: $235,527 - $295,172 

The range provided 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 shutdown, tuition reimbursement & loan repayment assistance, paid parental leave, generous commuter subsidy, and much more.

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.