Quality Assurance Manager - Cell & Gene Therapy

The QA Manager oversees quality management activities for DaVita Hospital Group’s Cell and Gene Therapy collection services, ensuring compliance with FDA, industry standards, and biopharma requirements.

Location: Brentwood, Tennessee, United States of America

Salary: $78,000.00 - $119,000.00 per year

Responsibilities

• Build and manage a compliant QMS covering donor eligibility, informed consent, apheresis/cell-collection processes, labeling, and packaging workflows.
• Ensure compliance with FDA 21 CFR 1271, 210/211, FACT-JACIE standards, and other regulations. Prepare for audits and inspections.
• Oversee process mapping, SOPs, work instructions, batch records, document control, change control, deviation management, and CAPA.
• Lead quality risk management initiatives. Oversee vendor and supply management, including equipment qualification, calibration, and maintenance.
• Ensure robust Chain of Identity (COI) and Chain of Custody (COC) systems. Support electronic QMS (eQMS) implementation.
• Oversee training and competency programs for clinical and QA staff.
• Define quality metrics, KPIs, dashboards, and lead quality review processes.
• Lead global regulatory submissions and develop strategic roadmaps for market clearance.
• Act as liaison with regulatory bodies and internal teams to ensure compliance and review technical documentation.

Requirements

• Bachelor’s degree in a technical, scientific, or healthcare-related field.
• 3-5 years of experience in Quality Assurance leadership, preferably in Cell & Gene Therapy or GMP environments.
• Deep knowledge of FDA 21 CFR 1271, FACT-JACIE, and AABB standards.
• Experience with QMS development, audits, CAPA, and continuous improvement.
• Proficiency in QMS software/eQMS platforms and MS Office.

Benefits

• Comprehensive benefits including medical, dental, vision, 401(k) match, paid time off, PTO cash out.
• Support for family resources, EAP counseling, Headspace®, backup child and elder care, parental leave.
• Professional development programs and online training through StarLearning.

Additional Information

• Position requires up to 50% travel to collection sites and meetings.
• Physical activities include lifting up to 15 pounds, extended computer use, and sitting/standing for long periods.
• Fluent in written and verbal communication.
• Vision adequate for job duties.