Professional summary:* Senior Supply Chain Management: 20 + years cGMP/cGCP oversight of global Clinical and Manufacturing supply chain systems and suppliers under ICH, Annex 13, Health Canada, CFIA, FDA, USDA, USFWS, GACC, and MoH guidelines.* Senior level oversight of Phase I-III clinical supply chain for randomized, open label, and blinded studies (20 studies in 32 countries - APAC, EMEA, NA, LAM).* Expert ability to label, distribute, forecast, procure, expedite IMP, NIMP, small molecules and biologics in compliance with UK and EU QP, and global MoH regulatory guidelines to meet FPI.* Developed the complete supply chain for Zymeworks Inc. from startup: R&D warehouse/Manufacturing /Clinical logistics and the Procurement department – 100% retention over 5 years.Knowledge expert in key areas of global trade compliance for biologics (USFWS, USDA, FDA, CFIA, CBSA, EU Directives, CITES). Expertise and strategic use of incoterms 2020, Importer of Record responsibilities, customs documentation development, TDG compliance, VAT and GST recovery, cold chain packaging strategies, and courier selection.
Listed skills include Gmp, Gcp, Project Management Cmo Cro, Forecasting, and 43 others.