Profile
Dr.-Ing. Stephan Rönninger
Senior advisory experience across policy matters, quality management, regulatory compliance and supply chain resilience.
My Curriculum Vitae
30+ years in industry
An interdisciplinary perspective built across international pharmaceutical market leaders, association leadership, academia, and global regulatory standardisation — distilled into practical implementations — with a track record that governing bodies rely on.
Manufacturing at a site
Including process optimization, engineering, API manufacturing and milling, training, Quality Assurance, Quality Management and QMS lead responsibilities.
Global Quality Management
Including global QMS lead for the Pharma division, global auditor and external engagement.
External Affairs and Pharmacopoeia matters
Including External Affairs lead and management of Pharmacopoeia matters.
Shaping policy
Industry representation and contribution
- Leading company’s programs for external engagement.
- GMP/GDP and inspection management for the Manufacturing and Quality Expert Group in EFPIA over 10 years.
- Representing EFPIA in the International Council of Harmonization.
- Writing ICH Q9 Quality Risk Management.
- Contributing to ICH Q-IWG, ICH Q8, Q9 and Q10, GMP for APIs (ICH Q7) Q&A, the ICH Quality Discussion Group and the ICH training subcommittee between 2004 and 2024.
- Representing the company in IFPMA and EUCOPE.
Boards and academia
Additional mandates
Parenteral Drug Association
Board of the Parenteral Drug Association (PDA), elected Director in 2013–2018 and 2020, and lead of the Manufacturing and Quality Advisory Board in 2010–2013.
Academic appointments
Adjunct Assistant Professor at George Washington University, Washington D.C. (2016–2019) and Academic Visiting Expert at Duke-National University of Singapore (NUS), Singapore (2018–2025).