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Quality Assurance Manager - Cell & Gene Therapy

United States · remote · USD 78000-119000 annual

Role overview

Posting Date

07/08/20265200 Virginia Way, Brentwood, Tennessee, 37027-7569, 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. 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.

The Salary Range for the role is $78,000.00 - $119,000.00 per year.If a candidate is hired, they will be paid at least the minimum wage according to their geographical jurisdiction and the exemption status for the position.New York Exempt: New York City and Long Island: $66,300.00/year, Nassau, Suffolk, and Westchester counties: $66,300.00/year, Remainder of New York state: $62,353.20/year New York Non-exempt: New York City and Long Island: $17.00/hour, Nassau, Suffolk, and Westchester counties: $17.00/hour, Remainder of New York state: $16.00/hourWashington Exempt: $80,168.40/year Washington Non-exempt: Bellingham: $19.13/hour, Burien: $21.71/hour, Everette: $20.77/hour, Unincorporated King County: $20.82/hour, Renton: $21.57/hour, Seattle: $21.30/hour, Tukwila: $21.65/hour, Remainder of Washington state: $17.13/hour

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Quality Assurance Manager - Cell & Gene Therapy

Role overview

Posting Date

ESSENTIAL DUTIES AND RESPONSIBILITIES:

MINIMUM QUALIFICATIONS:

LANGUAGE SKILLS:

VISION REQUIREMENTS:

PHYSICAL DEMANDS:

TRAVEL AND TIME REQUIREMENTS:

What We’ll Provide: