Calvin Kim

Head of Quality Systems and Validation, Samsung Biologics

Seasoned GxP system quality professional with pharmaceutical/CRO/CMO experience in the areas of R&D, analytical method development, clinical trial/data management, manufacturing, IT enterprise architecture, computerized system validation, system life cycle, data integrity, data governance, and technology regulatory compliance. Both a team player and leader with proficiency in building effective relationships within global, cross-functional, cultural team setting – with creative problem solving/innovative process implementation, efficient communication, and technical writing skills, combined with background in biochemistry and computerized systems. Multilingual – English, Korean, Mandarin Chinese – with diverse cultural backgrounds and a global perspective, seeking new opportunities to not only adapt quickly to the dynamic global community, but to challenge the status quo, gain new knowledge, innovate, and enhance GxP/Part 11/Annex 11 regulated industry standards through collaboration with diverse industry colleagues.