Hue Kwon PhD SOBI

Dr. Hue Kwon is the Global Head of Quality External Operations at SOBI to manage a global team to ensure quality oversight of all outsourced GMP activities and CDMOs and CLOs. She has been advising and consulting internationally as a senior advisor consultant on GxP quality maturity and digital transformation for various pharma/biotech organizations. She has over 20 years of experience in GxP quality and regulatory strategies from working within the biopharmaceutical industry including being a Vice President and Quality Team Leader at Samsung Bioepis providing GxP quality and compliance oversight for the end-to-end drug development and lifecycle and being the Head of Business Management and Head of Quality and Compliance in Roche, as a member of a senior management team and leading international GxP capability building and interaction with foreign regulatory agencies to influence in the decision making and building consensus. Until December 2010, she served at US FDA for about 9 years on the development of regulatory guidance, emerging regulatory strategy and review and data integrity inspections.