[Hiring] Quality Assurance Manager @DaVita Kidney Care

Role Description

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. This role 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 lifecycles and marketing claims meet FDA, ISO, and international standards.

Qualifications

• 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.

Requirements

• Fluent in the written and verbal skills necessary to perform successfully the essential functions, duties, and responsibilities of the position.
• Vision adequate to perform essential duties and responsibilities of position.
• Ability to lift minimum of 5 pounds to a maximum of 15 pounds unassisted; able to sit for extended periods of time and to perform some standing, stooping, walking, stretching, reaching; moderate range of body motions.
• Ability to use computer and all peripherals for extended periods of time (hand/finger dexterity) to meet performance goals and submit deliverables within deadlines.
• Potential of travel up to 50% to collection sites for audit preparation and activities and for meetings with external partners and internal stakeholders.

Benefits

• 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.