H. Joy Sharp

FDA Experience

Joy’s tenure with the FDA included service in the Center for Drug Evaluation and Research Office of Pharmaceutical Quality, Office of Policy for Pharmaceutical Quality, Office of Compliance, Office of Food Policy and Response (Office of the Commissioner), the Center for Food Safety and Applied Nutrition and the Office of Regulatory Affairs (Office of Import Operations). 

While at the FDA, Joy advised on many aspects of drug and biological product policy, including inspectional authority, matters of product jurisdiction, scope of statutory authority, and applicability of current regulatory regime to various Agency initiatives (e.g., elements of the Framework for Regulatory Advanced Manufacturing (FRAME) initiative (distributed manufacturing, point of care, interplay with in-process testing policy and other complex regulatory matters)); the Agency’s platform technology designation program; and quality metrics and quality management maturity initiatives. Joy advised senior imports and field leadership in the areas of imports review process, sampling strategy, import alerts and administrative detention, prior notice, and Automated Commercial Environment data set and process requirements. Joy also supported implementation of the FDA’s New Era of Smarter Food Safety, participated at a senior level in the drafting and implementation of the Food Safety Modernization Act (FSMA) and its foundational rules and programs, and led the drafting and facilitated publishing of the FDA’s Strategy for the Safety of Imported Food.

Joy is uniquely equipped to support clients in the drug and biologics industries, as her FDA regulatory experience provides insight on Current Good Manufacturing Practice (CGMP) for finished drug (small and large molecule), active pharmaceutical ingredient (API),and excipient manufacturers, as well as on FDA’s use of ICH quality guidelines, foreign and domestic inspectional policy, recall scope and depth, post-marketing reporting, biological product licensing — required elements and review process, quality metrics and quality management maturity initiatives, Good Guidance Practice (GGP), and more. When providing guidance to clients in the food and beverage industries, Joy can tap into her experience with areas including import certification, prior notice, the Food Safety Modernization Act (FSMA), the Preventive Controls and Produce Safety rules, the Foreign Supplier Verification Programs (FSVP), Accredited Third-Party Certification Program, Voluntary Qualified Importer Program (VQIP), traceability and more.

Transportation Experience

Prior to her work with the FDA, Joy spent nearly a decade providing legal guidance in the transportation (air freight-forwarding, ground carriage) and logistics industry. She drafted and implemented the security protocol for 135 distribution centers; advised the fleet safety director for the then-largest private fleet of tractor-trailers in the world; and negotiated vehicle leases, freight-forwarding/logistics contracts and corporate airplane sales.

Personal Interests

Joy is an accomplished classical pianist and is active in her beloved piano club. When there is no piano around, Joy likes to read, garden and spend time with her family.