Profile Thomas Guebeli, PhD
Professional with more than 30 years experience in various functions in Analytical R&D, Technical R&D, Manufacturing and Quality Operations in Pharmaceutical Industry
Thomas Guebeli
Educations and Certifications
- Master Degree in Pharmaceutical Sciences, University of Bern, Switzerland (1985)
- PhD in Analytical Chemistry, University of Bern, Switzerland (1989)
- Visiting Scientist, University of Washington, Center for Process Analytical Chemistry, Seattle, USA (1989-1991)
Career
- Head of analytical laboratory, Sandoz Pharma, Basel, Switzerland (1992-1994)
- Job Rotatee to Sandoz Pharmaceuticals Japan, Analytical R&D, Tsukuba, Japan (1995-1996)
- Head of Analytical R&D in Chemical & Analytical Development, CHAD, Sandoz Pharma, Basel, Switzerland (1996)
- Head of Analytical R&D in Chemical & Analytical Development, CHAD, Novartis Pharma, Basel, Switzerland (1996-1997)
- Head of Technical Operations, Ivers-Lee Group, Burgdorf, Switzerland (1997-2006)
- Senior Director International Quality Operations, Celgene International, Boudry, Switzerland (2006-2011)
- Executive Director International Quality Operations, Celgene International, Boudry, Switzerland (2011-2018)
- Executive Director Global Affiliates Quality & QP Operations, Celgene International, Boudry, Switzerland (2019 -> 2020)
- Executive Director, Global Quality, Celgene International, a Bristol-Myers Squibb Company, Boudry, Switzerland (2020)
- Founder and Principle Consultant of PRO Pharma Consulting GmbH, Burgdorf, Switzerland (2020 -> to date)
- VP, Global QA ad interim at a global Biopharmaceutical Company (2022)
- Lecturer CAS Pharmaceuticals Module at ETHZ, Zürich, Switzerland (2022 -> to date)
Core Competencies
Quality Management System Implementation:
- Building QMS in an R&D environment (e.g. built the first GMP-compliant QMS at Sandoz KK Japan)
- Building QMS for manufacturing and international distribution (1st Quality employee of Celgene International)
Building Quality Organizations:
- Built the Quality organization of Celgene International from scratch
- Created the QA Logistics function of Celgene Logistics
- Lead transition from the regional to a global Quality Organization (Global internal manufacturing Quality)
Internal and external Manufacturing QA, QC, and GDP oversight:
- On hands experience in Analytical R&D
- QA oversight of 3 manufacturing sites (one API, two SD-sites), being a Qualified Person for all sites, QA oversight of EU QP operations
- Oversight of CMOs and distributors (solid dose, sterile manufacturing, testing, distributors)
Affiliates/In-Market Quality Management:
- Established the global Affiliates Quality function and Affiliates QA support organization
- Established and lead Annual Affiliates Quality meetings (up to 30 countries participating)
GMP/GDP Compliance:
- Excellent track record of GMP and GDP inspections under responsibility of Thomas Guebeli (hosted more than 20 HA inspections of Swiss manufacturing sites)