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).

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.

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.

Quality Assurance Manager – Cell & Gene Therapy

Key skills