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Sr. Manager, Quality CSV at Genetix Biotherapeutics - ApplyBlast

Sr. Manager, Quality CSV

Genetix Biotherapeutics

5 months ago

Somerville, MA

Hybrid

Full Time

Senior

1 applicant

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About this role

A Senior Manager, QA Computer System Validation (CSV) at Genetix Biotherapeutics oversees the validation and compliance of GxP-regulated computerized systems, ensuring they meet global regulatory requirements and internal procedures. The role involves QA oversight for system implementations, upgrades, and decommissioning, as well as managing data integrity programs and supporting audits.

Skills

Qualifications

Bachelors’ DegreeMaster’s DegreeComputer SystemsEngineeringGxP Environment

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.