Skills: Data collection and analysis, Quality Management, Process Improvement, Regulatory Compliance, Team management, Staff development● Acting as the Cell Therapy main point of contact and reporting official with the FDA for renewing annual HCT/P establishment registration, reporting of Biological Product Deviations and Adverse events and other communications ● Overseeing all operations of the Cell Therapy Facility Quality Assurance Unit (QAU)● Maintaining and improving the quality management program for the Cell Therapy Facility.● Designing reports, maintaining and performing standardized statistical methods for the analysis of Cell Therapy quality assurance data● Directing and performing software qualification to comply with FDA CFR21.11 regulations.● Ensuring compliance with Federal regulations and accrediting bodies. Obtaining re-certification with CAP, CLIA and AABB in 2012 and 2014; and with FACT in 2013● Executing the release of manufactured Bone Marrow Transplant and therapeutic cell products for clinical use.● Managing, troubleshooting and improving electronic QA systems including Access databases● Writing, maintaining and performing standardized statistical methods for the analysis of Cell Therapy data● Generating reports of collection and processing data to support the Cell Therapy management/production team and the BMT research team for a variety of functions; including statistical data for research purposes and submission for publications

Skills: Process Improvement, Data collection and analysis, Regulatory Compliance, Process design, Database design● Establishing the Quality Management Program for the Cell Therapy Facility in 2003 with the CTF Director● Overseeing all operations of the Cell Therapy Quality Assurance Unit● Designing and implementing necessary processes for complying with newly introduced (May of 2005) cGTP regulations for human cells products from the FDA.● Reviewing and revising policies and procedures, obtaining re-certification with CAP, CLIA and AABB in 2004, 2006, 2008 and 2010; and with FACT in 2004, 2007, and 2010.● Designing, implementing and executing system of release of manufactured Bone Marrow Transplant and therapeutic cell products for clinical use; placing holds on nonconforming products ● Designing database system to detect and track Cell Therapy deviations● Planning and implementing corrective and preventive actions to deviations and non-conformances● Designing and maintaining databases for the capture and tracking of training, equipment maintenance, process change and other quality related data● Supervising QA staff and training Cell Therapy team on quality and regulatory compliance