President
Current Global Product Development from Concepts to Commercialization – Lead cross-functional product development teams to develop and launch products from concepts, formulation, prototypes, regulatory review, claim development and substantiation, specifications development (ingredients, products, and process control), testing method development, R&D scale-up, production scale-up and verification, supplier and contract manufacturer qualification and verification, to technology transfer. Global Product Registration and Product Filing – Work with government agencies and outside consultants, and internal cross-functional teams to register and file food, dietary supplement, and cosmetics products in the US, China, Southeast Asia, Canada, and other countries. Quality Systems Development and Implementation - cGMPs (Dietary Supplement, Food, Cosmetics, OTC, etc.), GLP, and GCP Food Safety Systems Development and Implementation - FSMA, FSVP, HACCP, SQF, GFSI, etc. Regulatory Compliance – Correspond with FDA to resolve 483s and warning letters, file GRAS and NDI Notifications, perform labeling review, etc. Quality Assurance – Develop corporation quality policy, develop and implement SOPs and process controls, conduct supplier audits, prepare for FDA/customer/certification audits, develop and implement corrective actions and preventive actions (CAPAs), hire/train/coach quality assurance team. Quality System and Food Safety System Audits – Conduct cGMPs (Dietary Supplement, Food, Cosmetics, OTC)/GLP/GCP audit and food safety (FSMA, FSVP, IA, HACCP, SQF, GFSI, etc.) audit. Supplier Qualification – Conduct supplier audits, establish processing and product specifications, establish Quality Agreements, and evaluate supplier performance Private and Public Training – Quality and Food Safety Systems and Regulatory Compliance
