EAS Consulting Group is pleased to welcome Shelly Blackwell to the EAS management team. As Senior Director for Dietary Supplements and Tobacco, she will be responsible for overseeing safety, submissions, and general regulatory intelligence under the purview of FDA, USDA, FTC, and various state agencies.
Shelly Blackwell brings over 22 years of quality and compliance experience in highly regulated environments to the EAS Consulting Group. After starting her career as a Microbiologist, she gained expert knowledge of a variety of domestic and international regulations while holding senior leadership positions in the dietary supplement, pharmaceutical, and medical device industries. These positions include 7 years as the Quality Assurance Director for GNC / Nutra Manufacturing and most recently leading the Quality Systems and Compliance Team at Bausch and Lomb in Greenville, SC.
Shelly’s accomplishments while leading Quality teams include developing supplier qualification programs, sourcing and implementing electronic QMS systems, implementing inspection readiness programs resulting in improved regulatory standing, risk-based quality system development, data integrity program development, and numerous successful continuous improvement initiatives. She has lead FDA and other regulatory inspections throughout her career and is also a lead auditor herself, auditing raw material suppliers and finished product manufacturers all over the world. Shelly holds certifications from the American Society of Quality and the Institute of Food Technology and has a Biology degree from James Madison University.
Posted in Dietary Supplements, EAS in Action, Extra Article, Tobacco.