BS, Biology
Montclair State University, Upper Montclair, NJ
Tammy Lesko, is Senior Director in the Office of Quality at RTI Health Solutions and Discovery Sciences. Ms. Lesko is a seasoned Quality Assurance professional and leader with over thirty years’ experience. She has experience in Sponsor companies, multiple Contract Research Organizations, an independent IRB, the US Food and Drug Administration and a generic pharmaceutical manufacturer. She has spent over twenty-two years in a managerial capacity where oversight of budgets, staff, recruitment, audit plans, sponsor audit support, inspection management, conflict resolution, negotiation, client management and strategic vision were performed for global teams and studies. She has successfully hosted numerous regulatory inspections (US FDA & Japan PMDA) in several countries (US, Japan, UK, France, Germany and South Africa) and provided support to inspections for MHRA, EMA, Health Canada, MCC and TFDA as well. Tammy has actively presented at industry conferences, provided training presentations for several employers in topics such as GCP/Human Subject Protection as well as provided inspection training to the Taiwanese FDA Investigators and Reviewers (invited by TFDA in 2012 & 2014).