Kerstin Koenig, PhD is the Head of Research & Development Quality, Bristol Myers Squibb. In this role, she is responsible for the development and strategic oversight of the world-wide quality assurance and quality management activities in the area of Product Development Quality, GLP, GCP and GVP. Her current work interests are the evolution of QMS e.g., Quality Risk Management, Quality by Design, Quality Culture; the role of technology e.g.; Data Analytics, and Auditing in the future. Kerstin is a member of the board of the German Quality Management Association and a team member of the CTTI Quality by Design Adoption initiative. She represents EFPIA as Topic Lead in the ICH E8 (R1) Expert Working Group.