Senior Director, Quality Ops – Cell & Gene Therapy

Regulatory Jobs; Somerville (MA); Hybrid; USD 250,000 - 302,000; Full time

Benefits offered by this job

Health, life and disability insurance

Employer 401(k) with match

Tuition reimbursement & loan repayment

Job summary

Genetix Biotherapeutics seeks a Senior Director, Quality Operations to lead the quality function for external manufacturing and testing oversight across clinical and commercial products. The role requires strategic leadership in a virtual model, ensuring CDMOs and laboratories comply with global regulatory standards and company QMS.

Based in Somerville, MA with a hybrid schedule, this position partners with Manufacturing, Regulatory, Medical, and Commercial teams to ensure uninterrupted patient

Qualifications

• 12+ years of progressive experience in Quality Operations, External Quality, or Manufacturing.
• Prior people leadership experience at Director or Senior Director level.
• Experience supporting commercial-stage products and post-approval lifecycle management.

Responsibilities

• Provide end-to-end External Manufacturing Quality Oversight of CDMOs and testing labs.
• Oversee commercial product release, disposition, and lifecycle management.
• Lead regulatory inspections readiness and support regulatory filings.
• Manage CDMO audit observations, deviations, and CAPAs to closure.
• Drive quality systems, governance, and metrics for a virtual operating model.
• Coach and develop the Quality Operations team and partners.

Skills

Leadership

GMP knowledge

Strategic planning

Cross-functional collaboration

Executive communication

Education

Bachelor’s degree in Life Sciences or related

Advanced degree preferred

Job description

Genetix Biotherapeutics seeks a Senior Director, Quality Operations to lead the quality function for external manufacturing and testing oversight across clinical and commercial products. The role requires strategic leadership in a virtual model, ensuring CDMOs and laboratories comply with global regulatory standards and company QMS.

Based in Somerville, MA with a hybrid schedule, this position partners with Manufacturing, Regulatory, Medical, and Commercial teams to ensure uninterrupted patient