Quality Assurance Manager - Cell & Gene Therapy

Posting Date

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
The following duties and responsibilities generally reflect the expectations of this position but are not intended to be all-inclusive:

• 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.

ESSENTIAL BEHAVIORS, SKILLS, AND ATTITUDES REQUIRED FOR SUCCESS IN THIS POSITION:

• 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.

MINIMUM 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.

LANGUAGE SKILLS:

• Fluent in the written and verbal skills necessary to perform successfully the essential functions, duties, and responsibilities of the position.

VISION REQUIREMENTS:

• Vision adequate to perform essential duties and responsibilities of position.

PHYSICAL DEMANDS:

Physical requirements can vary. These must be reviewed with management. However, in general, the position requires the following physical activities:

• 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.

TRAVEL AND TIME REQUIREMENTS:

• Potential of travel up to 50% to collection sites for audit preparation and activities and for meetings with external partners and internal stakeholders.

What We'll Provide:

More than just pay, our DaVita Rewards package connects teammates to what matters most. Teammates are eligible to begin receiving benefits on the first day of the month following or coinciding with one month of continuous employment. Below are some of our benefit offerings.

• 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.

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At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and comply with state and federal affirmative action requirements. Individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic.

This position will be open for a minimum of three days.

Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at https://careers.davita.com/benefits

Colorado Residents: Please do not respond to any questions in this initial application that may seek age-identifying information such as age, date of birth, or dates of school attendance or graduation. You may also redact this information from any materials you submit during the application process. You will not be penalized for redacting or removing this information.

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DaVita will never ask for payment or personal financial information at any point in the hiring process, nor will we ever communicate with you using email addresses outside of the DaVita secure network. If you receive a request like this, it is not legitimate. Do not share your information.

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