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Quality Assurance Manager - Cell & Gene Therapy at DaVita - ApplyBlast

Quality Assurance Manager - Cell & Gene Therapy

DaVita

3 months ago

3.3 on Glassdoor

Tennessee

Hybrid

Full Time

Senior

0 applicants

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About this role

The QA Manager develops and oversees the Quality Management System for DaVita Hospital Group's Cell and Gene Therapy collection services. This role ensures compliance with FDA regulations and industry standards like FACT-JACIE while driving quality standards across end-to-end cell collections to guarantee patient safety and product efficacy.

Responsibilities

Build and manage a fully compliant centralized Quality Management System
Ensure compliance with FDA regulations and industry standards
Oversee process mapping and creation of standard operating procedures
Lead quality risk management initiatives and vendor management processes
Define quality metrics and lead the Quality Management Review structure

Skills

Qualifications

Bachelor's degree in technical, scientific, or healthcare-related field

About DaVita

davita.com

Headquarters

Denver, Colorado, United States

Company Size

10001+ employees

Founded

1999

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DaVita is a leading provider of kidney care services, offering dialysis treatments (in-center and home-based), chronic kidney disease education, and integrated care support for patients managing CKD and end-stage kidney disease. The company operates dialysis centers nationwide and provides tools and resources including dietitian-developed recipes, GFR calculators, and kidney health classes. DaVita also partners with hospitals, health plans, and skilled nursing facilities to deliver comprehensive kidney care solutions.