Director of Quality Assurance and Regulatory Compliance

16 hours ago


Cincinnati, Ohio, United States University of Cincinnati Full time
Job Overview

The University of Cincinnati's Hoxworth Blood Center is seeking a highly skilled Director of Quality Assurance and Regulatory Compliance to oversee the coordination of quality assurance and regulatory compliance for the Cellular Therapy, Therapeutic Apheresis, and Transplantation Immunology divisions.

Key Responsibilities
  • Direct the coordination of regulatory compliance with the Food and Drug Administration (FDA), including review of changes to regulations and FDA guidance documents, submission of biological product deviation reports to the FDA, and response to observations or findings from an FDA inspection.
  • Support the Division Director in the preparation of license applications to the FDA, the annual report of minor changes to the FDA, and necessary correspondence with the FDA.
  • Manage the quality programs necessary for maintaining applicable licensure and accreditation, including internal and external audits, supplier qualifications, change control, deviation management, document control, and record retention.
  • Develop departmental SOPs for new processes and update existing SOPs, keeping abreast of state regulations governing compliance.
  • Oversee the development and execution of educational programs for staff regarding quality assurance, Good Manufacturing Practices (GMP), and regulatory compliance for staff and students.
  • Maintain professional growth, represent the University at meetings/seminars, and serve on various committees.
  • May provide direct and/or indirect supervision to exempt and non-exempt staff, including hiring/firing, performance evaluations, disciplinary action, approving time off, etc.
Requirements
  • Bachelor's Degree in Medical Technology, Biology, Chemistry, or related field.
  • Seven (7) years of experience in a clinical laboratory, blood banking, or other related experience.
  • Previous experience in a FACT, AABB, and HCT/P (21 CFR 1271) setting is ideal.
  • Understanding of CAP requirements for histocompatibility (HLA) laboratories, including disciplines of sequencing, molecular, serological, immunology, flow cytometry, and cellular analysis is ideal.


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