Quality Assurance Manager - Cell & Gene Therapy

Posting Date 07/08/ Virginia Way, Brentwood, Tennessee, , United States of America

This position develops, implements, and oversees activities under the Quality Management System (QMS) for DaVita Hospital Group’s Cell and Gene Therapy (CGT) collection services. The QA Manager is responsible for ensuring that all apheresis and cell collection operations are fully compliant with FDA regulations, industry standards such as FACT‑JACIE and AABB, and biopharma manufacturer requirements. The QA Manager will drive quality standards across end‑to‑end cell collections to ensure patient safety, product efficacy, and regulatory compliance.

• QMS Development & Implementation:
  Build and manage a fully compliant, centralized QMS covering donor eligibility, informed consent, apheresis/cell‑collection processes, labeling, and packaging workflows.
• Compliance & Audit Readiness:
  Ensure compliance with FDA 21 CFR 1271, 210/211, FACT‑JACIE standards, and other applicable local regulations. Prepare for and manage internal audits, regulatory inspections, and biopharma manufacturer audits.
• Document & Process Control:
  Oversee process mapping and the creation of SOPs, work instructions, and batch records. Manage document control, change control, deviation management, and Corrective and Preventive Actions (CAPA).
• Quality Risk & Vendor Management:
  Lead quality risk management initiatives. Oversee vendor and supply management processes, including equipment qualification, calibration, and maintenance protocols in partnership with internal stakeholders.
• Traceability & Systems:
  Ensure robust Chain of Identity (COI) and Chain of Custody (COC) systems are integrated seamlessly with collection procedures. Support the implementation and maintenance of electronic QMS (eQMS) solution and mapping to supporting IT solutions.
• Training &
  
  Competency:
  
  Oversee training and competency management programs for clinical and QA staff performing CGT collections.
• Performance Monitoring:
  Define quality metrics, KPIs, and dashboards. Lead the Quality Management Review structure and continuously promote quality achievements and performance improvements throughout the organization.
• Global Submission & Strategy Management:
  Lead the end‑to‑end preparation, filing, and maintenance of global regulatory submissions (e.g., 510(k), PMA, EU MDR) and develop strategic roadmaps to ensure timely market clearance for new and existing medical devices.
• Compliance & Cross‑Functional Oversight:
  Act as the primary liaison with regulatory bodies and internal QMS leadership to ensure compliance to regulatory standards, risk management, and the review of technical documentation to ensure all product life cycles and marketing claims meet FDA, ISO, and international standards.

• Commitment to DaVita’s values of Service Excellence, Integrity, Team, Continuous Improvement, Accountability, Fulfillment, and Fun.
• Demonstrated ability to lead cross‑functional teams and drive complex quality initiatives in a rapidly evolving clinical and regulatory landscape.
• High attention to detail and rigorous commitment to patient safety and regulatory compliance.
• Excellent written and verbal communication skills, with the ability to articulate complex quality and compliance standards to clinical staff, executives, and external partners.
• Strong problem‑solving and analytical skills, with a proactive approach to risk management, deviation resolution, and CAPA execution.
• Adaptability and resilience to navigate ambiguity and build processes from the ground up.
• Collaborative mindset with the ability to foster trust and strong relationships with hospital partners, biopharma manufacturers, and internal stakeholders.

• 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,…