Director, Quality Assurance/Regulatory Affairs

Hoxworth Blood Center (HBC) was founded in 1938 and serves more than 30 hospitals in 18 counties in Ohio, Kentucky, and Indiana. Annually, HBC collects more than 100,000 units of blood from local donors to help save the lives of patients in area hospitals. HBC is located within the University of Cincinnati (UC), College of Medicine, and is seeking a full-time Director, to oversee and direct the coordination of quality assurance and regulatory compliance for the collection, manufacture, storage and distribution of licensed and unlicensed blood and blood components, and for the testing of donor and patient samples. Essential Functions: Direct the coordination of regulatory compliance with the Food & Drug Administration (FDA), e.g. review of changes to regulations & guidance documents, submission of biological product deviation reports & response to observations/findings from FDA inspections. Support the Division Director in the preparation of license applications, annual report of minor changes & correspondence with the FDA. Manage the quality programs for maintaining applicable licensure and accreditation, e.g. internal and external audits, supplier qualifications, change control, deviation management, document control and record retention. Minimum Requirements: Bachelor’s Degree and seven (7) years’ experience. Click HERE for the full job description and to apply. EOE