Quality Assurance Manager – Cell & Gene Therapy

🕒 July 8

🎸 Tennessee – Remote

🎸 Tennessee – Remote

💵 $78k - $119k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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DaVita Kidney Care

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1994

🏥 Healthcare

⚕️ Healthcare Insurance

💰 Post-IPO Debt on 2021-02

Healthcare • Healthcare Insurance

DaVita Kidney Care is a leading healthcare company that provides dialysis and related treatments for patients with kidney disease. Committed to improving the quality of life for its patients, DaVita focuses on offering integrated kidney care and supporting its diverse team of healthcare professionals, including nurses, dietitians, social workers, and patient care technicians. The company emphasizes a strong culture, career development, and comprehensive benefits to create an inclusive and supportive work environment for its employees.

📋 Description

• 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

• 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

• 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.