Maintains a robust Quality Management (QM) program in concert with the Cell Therapies Facility (CTF)Technical Director, Scientific Director and Medical Director. 

The QM Director will maintain compliance with standards of the Foundation for Accreditation of Cellular Therapy (FACT), the College of American Pathologists (CAP), as well as provisions of FDA current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP). In addition, the QM Director will coordinate quality agreements with internal and external sponsors of cell therapy development and manufacturing for experimental clinical trials. At minimum, this will include identification, monitoring and trending of critical quality metrics, audits, document control, process control, change control, facility and equipment control, personnel control, deviation control and records management.

The QM Director is responsible for routine reporting to senior leadership and all required external regulatory and accreditation agencies. The incumbent will be expected to participate in creation of the Chemistry, Manufacturing and Control (CMC) module of Investigational New Drug (IND) applications to the FDA. 

The QM Director will be an active participant in strategic planning on operations of the CTF at Moffitt Cancer Center.