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Manager, Quality Assurance Operations at Genetix Biotherapeutics - ApplyBlast

Manager, Quality Assurance Operations

Genetix Biotherapeutics

3 months ago

Somerville, MA

Onsite

Full Time

Senior

3 applicants

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About this role

The Manager, Quality Assurance Operations role provides end-to-end quality oversight of Contract Manufacturing Organizations (CMOs) to ensure compliance with cGMP regulations and company standards. This position serves as the primary quality interface with external partners, driving proactive risk management and managing the lifecycle of deviations and change controls. The role involves leading governance forums, reviewing validation deliverables, and monitoring CMO performance metrics to drive continuous improvement.

Responsibilities

Provide end-to-end quality oversight of Contract Manufacturing Organizations
Lead QA-to-QA forums and joint governance meetings with external partners
Review and approve internal and external CMO deviations and change controls
Monitor CMO quality performance metrics and drive continuous improvement
Author and review Annual Product Quality Reviews for comprehensive evaluation

Skills

Qualifications

Bachelor's degree in Life Sciences or Engineering7+ years of Quality Assurance experience in GMP-regulated environments

About Genetix Biotherapeutics

genetixbiotx.com

Headquarters

Somerville, Massachusetts, United States

Company Size

1-10 employees

Founded

1993

View Profile

Genetix Biotherapeutics, formerly bluebird bio, is a biotechnology company focused on developing and commercializing transformative one-time genetic therapies for patients with rare diseases, including sickle cell disease, β-thalassemia, and cerebral adrenoleukodystrophy. The company markets three FDA-approved therapies—LYFGENIA, ZYNTEGLO, and SKYSONA—which are designed to treat the underlying genetic cause of disease using the patient's own blood stem cells. As a privately held company, Genetix Biotherapeutics is focused on commercial execution, scaling patient access, and improving the treatment experience for patients and providers.