Bobbie Carter Director of Quality Assurance
Bobbie Carter comes to Dart Neurosciences with over 25 years of science and industry-related experience, 13 of which she has spent managing Quality Systems and ensuring compliance at biologics, device, and pharmaceutical companies. In her most recent role as Quality Assurance Director, she gained valuable experience in driving compliance as the company moved through a major transition from primarily research-oriented to commercial pharmaceutical development. During this time she successfully managed and passed multiple FDA Pre-Approval Inspections, leading to a drug approval in 2012. Bobbie has set up and managed Quality Assurance, Document Control, Materials Management, Validation, Internal and External Auditing, Metrology, and Operations departments, and has utilized various electronic systems. She has worked with partners, contract manufacturing and research organizations worldwide, with involvement in project initiation, technology transfer, and quality oversight. While her primary focus has been GMP related-activities, Bobbie is also well-versed in GLP and GCP regulations and requirements, and has experience supporting pre-clinical studies and all phases of clinical trials. She has also supported implementation of various post-marketing quality processes. She truly enjoys working in a collaborative environment, and believes that the development and motivation of team members is a key to a successful Quality System. Bobbie holds a B.S. in Chemistry from Savannah State University and has received extensive training in managing Quality Systems.