Quality Assurance Manager – Cell & Gene Therapy

DaVita Kidney Care

Quality Assurance Manager overseeing QMS and compliance for Cell and Gene Therapy operations. Ensuring patient safety and regulatory requirements are met in Brentwood, Tennessee.

Posted 7/8/2026full-timeRemote • Tennessee • 🇺🇸 United StatesMid-LevelSenior💰 $78,000 - $119,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Management Systems (QMS) for Cell and Gene Therapy, ensuring compliance with FDA regulations and industry standards while leading audits and continuous improvement initiatives.

Highest-signal resume keywords

Quality Management System (QMS)FDA Regulations ComplianceCell And Gene Therapy (CGT)Audit ManagementCAPA Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Assurance LeadershipRegulatory Submissions (510(k), PMA, EU MDR)Apheresis ProcessesGMP/GTP Environment ExperienceQMS Initiatives Development

Soft Skills

LeadershipTraining ManagementCommunication

Tools & Technologies

QMS SoftwareEQMS PlatformsMS Office Suite

Industry Keywords

FACT-JACIE StandardsAABB StandardsDonor EligibilityInformed ConsentRegulatory Inspections

About the role

Key responsibilities & impact

Develop, implement, and oversee activities under the Quality Management System (QMS) for Cell and Gene Therapy (CGT) collection services.
Ensure compliance with FDA regulations, industry standards (such as FACT-JACIE and AABB), and biopharma manufacturer requirements.
Drive quality standards across end-to-end cell collections to ensure patient safety, product efficacy, and regulatory compliance.
Build and manage a fully compliant, centralized QMS covering donor eligibility, informed consent, apheresis/cell-collection processes, labeling, and packaging workflows.
Prepare for and manage internal audits, regulatory inspections, and biopharma manufacturer audits.
Oversee training and competency management programs for clinical and QA staff performing CGT collections.
Lead the end-to-end preparation, filing, and maintenance of global regulatory submissions (e.g., 510(k), PMA, EU MDR).

Requirements

What you’ll need

Bachelor’s degree in a technical, scientific, or healthcare-related field.
Minimum 3-5 years of experience in Quality Assurance leadership, supervisory, or management roles, preferably within Cell & Gene Therapy, apheresis, blood banking, or a strongly regulated GMP/GTP environment.
Deep knowledge of relevant regulatory frameworks, including FDA 21 CFR 1271, FACT-JACIE, and AABB standards.
Extensive experience with the planning, development, and implementation of QMS initiatives and quality standards.
Strong background in leading audits, CAPA management, and continuous improvement projects.
Intermediate to advanced computer skills and proficiency in QMS software/eQMS platforms, as well as MS Office suite.

Benefits

Comp & perks

Comprehensive benefits: Medical, dental, vision, 401(k) match, paid time off, PTO cash out
Support for you and your family: Family resources, EAP counseling sessions, access Headspace®, backup child and elder care, maternity/paternity leave and more
Professional development programs: DaVita offers a variety of programs to help strong performers grow within their career and also offers on-demand virtual leadership and development courses through DaVita’s online training platform StarLearning.