Quality Operations Director – External Manufacturing

Genetix Biotherapeutics; Boston (MA); Hybrid; USD 250,000 - 302,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Bonus eligibility

Job summary

Genetix Biotherapeutics in Somerville, MA, offers a full-time hybrid role for Senior Director, Quality Operations. The role ensures quality leadership across external manufacturing, testing oversight, lot disposition, and patient-specific controls for clinical and commercial supply in a virtual operating model.

You will partner with Manufacturing, Regulatory Affairs, Medical, Supply Chain, and Commercial teams to maintain uninterrupted, compliant patient supply, support inspections, and drive

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related discipline.
• 12+ years of progressive experience in Quality Operations or Manufacturing.
• Director or Senior Director level leadership experience.
• Experience supporting commercial-stage products and post-approval lifecycle.
• Deep knowledge of GMP regulations (FDA, EMA, ICH).
• Experience in virtual or highly outsourced operating models.

Responsibilities

• Provide external manufacturing quality oversight for clinical and commercial products.
• Establish CDMO quality agreements and oversee performance monitoring.
• Support compliant product release, disposition, and lifecycle management.
• Lead regulatory inspections and ensure timely resolution of findings.
• Drive quality systems and governance across a virtual network.
• Lead, mentor, and develop the Quality Operations team.

Skills

Quality leadership

Regulatory knowledge

Strategic thinking

Cross-functional collaboration

Executive presence

Education

Bachelor’s degree in Life Sciences or related field

Advanced degree preferred

Job description

Genetix Biotherapeutics in Somerville, MA, offers a full-time hybrid role for Senior Director, Quality Operations. The role ensures quality leadership across external manufacturing, testing oversight, lot disposition, and patient-specific controls for clinical and commercial supply in a virtual operating model.

You will partner with Manufacturing, Regulatory Affairs, Medical, Supply Chain, and Commercial teams to maintain uninterrupted, compliant patient supply, support inspections, and drive