Location
Durham
Posted
June 10, 2026
Commute
Local Area
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Job Description
:
Leadership & Strategic Direction Lead and develop a national Quality Operations team
Establish strategic priorities for Quality Operations aligned with corporate goals.
Ensure effective communication, collaboration, and alignment with Operations, Medical Affairs, Regulatory, and Quality counterparts. Compliance & Quality Oversight Ensure donor centers comply with US FDA, EMA, PPTA IQPP standards, CLIA/COLA, and state regulations.
Maintain audit and inspection readiness across all centers.
Oversee investigations, deviations, CAPAs, complaints, donor safety events, and product quality issues. Quality Management System (QMS) Oversee implementation and effectiveness of QMS elements at Donor Center level: Change Control, Document Management, CAPA, Training, Risk Management, Supplier Quality.
Ensure procedures are implemented consistently and updated accordi...