Sr. Director, Quality Operations

Genetix Biotherapeutics(26 days ago)

RemoteFull TimeDirector$200,693 - $266,318 (estimated)Quality

About this role

The Senior Director, Quality Operations provides strategic and operational oversight for externally manufactured cell and gene therapy products across clinical and commercial supply. This leader ensures CDMOs, testing labs, and other GxP service providers comply with global regulatory requirements and company quality standards within a virtual operating model. The role partners with cross-functional teams to maintain uninterrupted product supply and inspection readiness while leading and developing the Quality Operations team and advising senior leadership.

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Required Skills

Quality Oversight
CDMO Oversight
Quality Agreements
Product Release
Lifecycle Management
Deviations
CAPA Management
Change Control
Investigations
Lot Disposition

+17 more

Qualifications

Bachelor’s Degree in Life Sciences, Engineering or Related Discipline
Advanced Degree Preferred

About Genetix Biotherapeutics

genetixbiotx.com

Genetix Biotherapeutics (formerly bluebird bio) is a biopharmaceutical company focused on developing and delivering transformative genetic therapies for people living with sickle cell disease, β-thalassemia, and cerebral adrenoleukodystrophy. The company advances clinical programs and patient support services to bring novel gene-based treatments to individuals with severe inherited blood and neurological disorders. Headquartered in Somerville, MA, Genetix provides medical information, runs clinical trials, and offers dedicated patient support and outreach.