Independent Consultant

Christian Schmitz-Moormann

Consultant for Quality, Pharmacovigilance and Learning

Christian Schmitz-Moormann is an independent consultant, project manager and trainer with more than 25 years of experience in regulated life science processes and systems, focused on quality, pharmacovigilance and learning.
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Certifications

  • Diplom Biochemie, University of Bayreuth
  • Computer Software Validation Training
  • PRINCE2

For more than 25 years, Christian Schmitz-Moormann has helped large and small life science and software companies get their regulated processes and systems right. His main topics are quality, pharmacovigilance and learning. A biochemist by education, he was responsible for the validation of strictly regulated systems and led teams that connect business, IT and quality.

At a major software vendor, he worked with customers to match processes and systems and guided teams in building compliant products with agile and lean practices. For the past 10 years he has worked as an independent consultant, project manager and trainer, helping clients improve quality, compliance and value while technology changes quickly. He also works with clients on adding AI tools to the industry's toolbox for regulated environments. Christian is a recurring speaker at drug safety events.

Selected projects include supporting the build-up of a PMO and improvements to the PSMF process at a global pharmaceutical company, and advising a software vendor on an AI-first signal management solution. He managed the introduction of a global learning management system for more than 60 sites, and supported the integration of a Japanese affiliate into a global pharmacovigilance system.

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Spiral staircase in a bright, modern building
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Woman with curly hair wearing business attire, leaning on a glass balcony and looking up while holding a smartphone with both hands in a modern building with white structural beams.
Medical team walking along a glass corridor in a hospital
Modern office workstation in a clinical research facility
Two healthcare professionals talking on a glass balcony in a modern hospital
Three healthcare workers in scrubs taking a break and talking in a sunlit hospital hallway with large windows.
Modern office building with large glass windows reflecting its interior, showing orange letters spelling MAFINEX.