Kerstin Koenig
About Kerstin Koenig
Kerstin Koenig is the Vice President of Global Research Development Quality & Strategy Operations at Bristol Myers Squibb, with over 20 years of experience in drug development and extensive expertise in Quality Assurance.
Title
Kerstin Koenig currently holds the position of Vice President, Global Research Development Quality & Strategy Operations at Bristol Myers Squibb in Lawrenceville, New Jersey.
Company
Kerstin Koenig is currently working at Bristol Myers Squibb. She has contributed to the company's quality assurance and strategic operations development, having held multiple roles namely Vice President, Head Global Research Development Quality, and her current position as Vice President, Global Research Development Quality & Strategy Operations.
Previous Roles at Merck Group
Before joining Bristol Myers Squibb, Kerstin Koenig served at Merck Group. From 2015 to 2020, she was the Vice President, Head Global Research & Development Quality, and prior to that, she held the role of Senior Director, Head of Global Clinical Development QA from 2013 to 2015 in the Darmstadt Area, Germany.
Education and Expertise
Kerstin Koenig studied at the University of Bonn where she earned her PhD in Nutritional Science from 1987 to 1999. She has more than 20 years of experience across various pharma and biotech environments, specializing in GCP QA, GLP, GCLP, IT, and PV QA.
Professional Background
With an extensive background in quality management, Kerstin Koenig has held key positions at numerous organizations. She worked at Eli Lilly and Company / ImClone Systems as GQAAC Director - Medical / AVP Global Medical Quality Assurance from 2009 to 2013. Before that, she was an Associate Director at Pfizer from 2007 to 2009 and held multiple QA roles at Altana Pharma.
Quality Assurance and Compliance Expertise
Kerstin Koenig has played a pivotal role in developing Quality Assurance strategies and audit processes multiple times. She possesses substantial experience in restructuring quality groups, merging quality units, and implementing risk-based QA, Quality by Design, and Critical to Quality Factors. Her compliance expertise includes GLP, GCP, GVP, as well as FDA, EU, Japanese, and Chinese GCP/ICH regulations.