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 -> )

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)