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.

Global GMP/GDP compliance Strategy and external Policy

Amgen (Europe) GmbH, Rotkreuz · 2013–2026

Shape and execute the strategic direction of external affairs across global operations, ensuring robust governance in GMP/GDP, CMC compliance, supply chain resilience, and environmental accountability. Lead Pharmacopoeia engagement as a key pillar of long-term regulatory strategy.

Global Quality Management

F. Hoffmann La Roche AG, Basel · 2003–2013

Including global quality management system (QMS) lead for the Pharma division, global auditor and external engagement for operation policy and risk management.

Manufacturing at a site

Roche AG, Sisseln · 1992–2003

Including process optimisation, engineering, API manufacturing and milling, training, Quality Assurance, Quality Management and QMS lead responsibilities.

Postdoctoral researcher with Prof. Dr. A. Vasella

Uni Zürich, Zürich · 1989-1992
Shaping policy

Industry representation and contribution

  • Define, coordinate, and shape Policy Positions on GMP/GDP Compliance, CMC globally.
  • Ensure alignment with Government affairs, HTA, and global Regulatory Policy
  • Representing in the key industry associations including EFPIA, IFPMA, and PDA by monitoring, benchmarking, and shaping GxP, quality/CMC, and regulatory compliance
  • Representing in and for associations, EFPIA, IFPMA, and PDA in leadership roles.
  • Engage with regulatory bodies e.g. EC/EMA, ICH, PIC/S, WHO, APEC
  • Contributing in ICH to QRM (ICH Q9), Q-IWG (ICH Q8, Q9, and Q10), GMP for APIs (ICH Q7 Q&A), the ICH Quality Discussion Group and the ICH training between 2004 and 2024.
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).