avatar for Kerstin Koenig

Kerstin Koenig

Vice President, Global Head Research and Development Quality
Kerstin Koenig, PhD is the Head of Research & Development Quality, Merck Healthcare KGaA, Darmstadt, Germany. 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 Good Research Practice, Good Laboratory Practice, Good Clinical Practice and Good Vigilance Practice.  
Prior to joining Merck Healthcare KGaA, Darmstadt, Germany in May 2013, Kerstin spend almost 20 years of her professional career in Medical Quality Assurance Leadership positions with various Pharmaceutical companies.

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 (former DGGF) and a frequent speaker/session chair at national and international quality conferences. She is also a member of the TransCelerate’s clinical Quality Management System Realization team and a project lead for the CTTI Quality by Design Adoption initiative. Kerstin represents EFPIA as Topic Lead in the ICH E8 (R1) Expert Working Group.

Kerstin has a Diploma and a PhD in Nutrition Science from the University Bonn, Germany.

“Quality is everyone’s responsibility” W. Edwards Deming

My Speakers Sessions

Monday, February 24


Tuesday, February 25