Stephan Roenninger2

Dr.-ing Stephan Roenninger

Adjunct Assistant Professor
George Washington University

Quality External Affairs
Amgen (Europe)

Dr Stephan Rönninger is leading the Corporate Quality, External Affairs department on Amgen’s operations policy outreach and external ambassador program. He holds a PhD engineering degree in organic chemistry from the Technical University of Darmstadt, Germany and is appointed as Adjunct Assistant Professor of Clinical Research and Leadership at the Georges Washington University, Washington D.C., US. In his current role, he collaborates cross-functional worldwide with internal and external stakeholders on topics regarding GMP, GDP, CMC and Medical Device by providing subject matter expertize comments on regulatory guidelines, intelligence, and education.

He represents Amgen in and the European industry association EFPIA on technical development. He represents EFPIA in ICH on Q9, Q-IWG, the Q7-IWG and now on the ICH management sub-committee training. In PDA he is a director of the board, past-chair in RAQAB, co-chairs conferences and trainings e.g. with PIC/S.

Following his postdoctoral studies he worked for Roche in API manufacturing, laboratory and project management He served as a production manager, within QA since 1992. In 2003, he joined the Roche Global Quality organization with leadership for the Global Quality System and external collaborations. He joined Amgen in 2013.

He has received numerous awards and appreciations/recognitions, including from the US-FDA, Health Canada, Peru, South Korea, Turkey, PIC/S and PDA.