Job Information
University of Cincinnati Director, Quality Assurance & Regulatory Affairs, Hoxworth Blood Center in Cincinnati, Ohio
Director, Quality Assurance & Regulatory Affairs, Hoxworth Blood Center Current UC employees must apply internally via SuccessFactors > http://bit.ly/UCEMPL Founded in 1819, the University of Cincinnati ranks among the nation's best urban public research universities. Home to over 50,000 students, 11,000 faculty and staff and 332,000 alumni, UC combines a Top 35 public research university with a physical setting The New York Times calls "the most ambitious campus design program in the country." With the launch of Next Lives Here, the Cincinnati Innovation District, a $100 million JobsOhio investment, nine straight years of record enrollment, global leadership in cooperative education, a dynamic academic health center and entry into the Big 12 Conference, UC's momentum has never been stronger. UC's annual budget tops $1.65 billion and its endowment totals $1.8 billion. Job Overview The University of Cincinnati, Hoxworth Blood Center is recruiting for a full-time (100 % FTE), Director, Quality Assurance / Regulatory Affairs, to oversee and direct the coordination of quality assurance and regulatory compliance for the Cellular Therapy, Therapeutic Apheresis, and Transplantation Immunology divisions. Essential Functions Direct the coordination of regulatory compliance with the Food & Drug Administration (FDA), to include 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; to include but not limited to 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. Keep 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 (i.e., hiring/firing, performance evaluations, disciplinary action, approve time off, etc.). Perform related duties based on departmental need. This job description can be changed at any time. Required Education Bachelor's Degree inMedical Technology, Biology, Chemistry, or related field. Required Experience Seven (7) years of experience in a clinical laboratory, blood banking or other related experience. Additional Qualifications Considered Previous experience in a FACT, AABB and HCT/P (21 CFR 1271) setting is ideal. Previous experience in GMP (21 CFR 211) for Phase I/II clinical manufacturing, Regenerative Medicines, Cleanrooms, and Aseptic Processing is ideal. Understanding of CAP requirements for histocompatibility (HLA) laboratories which includes disciplines of sequencing, molecular, serological, immunology, flow cytometry, and cellular analysis is ideal. Physical Requirements/Work Environment Sitting - Continuously Hearing, listening - Often Repetitive hand motion (such as typing) - Often Standing - Often Talking - Often Walking - Often Bending - Seldom Climbing stairs/ladders - Seldom Crawling - Seldom Crouching - Seldom Kneeling, squatting - Seldom Pulling, pushing - Seldom Reaching overhead - Seldom Stooping - Seldom Compensation and Benefits UC offers a wide array of complementary
