Cell Therapy Quality Ops Leader | Hybrid

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

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Tuition reimbursement

Onsite parking

Commuter subsidy

Job summary

Genetix Biotherapeutics, located in Somerville, MA, is seeking a Senior Director of Quality Operations to lead strategic and operational quality oversight for external manufacturing and testing across clinical and commercial programs.

The role ensures full regulatory compliance with FDA/EMA/ICh guidelines in a virtual operating model, coordinating with Manufacturing, Regulatory Affairs, Medical, and Supply Chain teams to sustain patient supply and inspection readiness.

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.

Responsibilities

• Provide end-to-end external CDMO quality oversight for clinical and commercial products.
• Oversee commercial product release, disposition, and lifecycle management including CAPAs and investigations.
• Lead regulatory inspections readiness; coordinate audits and responses as a company representative.
• Manage CDMO vendor quality, deviations, and CAPAs to closure across the external network.
• Drive QMS governance, data integrity, change control, and documentation across external partners.
• Mentor and develop a high-performing Quality Operations team and partner with senior leadership.

Skills

Strategic leadership

Quality Operations

GMP compliance

CDMO oversight

Regulatory inspections

Cross-functional collaboration

Education

Bachelor’s degree in Life Sciences or related

Advanced degree preferred

Job description

Genetix Biotherapeutics, located in Somerville, MA, is seeking a Senior Director of Quality Operations to lead strategic and operational quality oversight for external manufacturing and testing across clinical and commercial programs.

The role ensures full regulatory compliance with FDA/EMA/ICh guidelines in a virtual operating model, coordinating with Manufacturing, Regulatory Affairs, Medical, and Supply Chain teams to sustain patient supply and inspection readiness.