Sr. Director, Quality Operations

The role

The Senior Director, Quality Operations provides strategic and operational leadership for commercial Quality Operations. This role oversees external manufacturing and testing, lot disposition, quality governance, and patient-specific product controls.

What you will do

• Provide end-to-end quality oversight of external manufacturers supporting clinical and commercial cell and gene therapy products.
• Establish and maintain CDMO quality agreements.
• Oversee performance monitoring and approval of CDMOs, testing laboratories, and logistics providers.
• Ensure compliant commercial product release, disposition, and lifecycle management.
• Oversee lot disposition activities in collaboration with internal stakeholders.
• Lead external quality readiness for FDA inspections and participate in regulatory inspections.
• Ensure effective management of CDMO audit observations, deviations, and CAPAs.
• Drive continuous improvement of external quality processes.
• Lead, mentor, and develop a high-performing Quality Operations team.
• Act as a strategic quality advisor to senior leadership and cross-functional teams.

Required qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related discipline
• 12+ years of progressive experience in Quality Operations, External Quality, or Manufacturing
• 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

Nice to have

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

Benefits

• comprehensive health, life and disability insurance
• employer-matched 401(k) plan
• lifestyle spending account
• flexible time-off
• paid holidays
• winter holiday period
• tuition reimbursement & loan repayment assistance
• paid parental leave
• paid onsite parking
• commuter subsidy

Before you apply

• Candidates must reside within a commutable distance of the office to be considered

About the company

Genetix Biotherapeutics is pursuing curative gene therapies to give patients and their families more days. The company is composed of doers, thinkers and collaborators who embrace values of innovation, diversity, and radical care.