Independent Consultant

Christian Nollert

GVP Expert, Trainer and Quality Manager

Christian Nollert is a GVP expert, trainer and DEKRA-certified quality manager and auditor with more than 15 years of experience in the life sciences industry.
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Certifications

  • DEKRA-Certified Quality Auditor (EQA)
  • DEKRA-Certified Quality Management Representative (QMB)
  • DEKRA-Certified Quality Manager (QMA)
  • Diplom-Biologe (Master of Science), University of Karlsruhe (KIT)

Christian Nollert is a Diplom-Biologist (University of Karlsruhe, KIT) with more than 15 years in the life sciences industry, mostly at international CROs. His core areas are pharmacovigilance (GVP), training and development, and quality management. He is a DEKRA-certified Quality Management Officer (QMB), Quality Manager (QMA) and External Quality Auditor (EQA) under ISO 9001:2015 and ISO 19011:2018.

As Senior Manager Learning & Development, he trained global teams on GVP and GCP requirements and ran inspection readiness programmes. He is now building an independent PV/GxP consulting practice that covers training, operations support and inspection readiness. He works in German and English.

His project experience includes co-founding a PV department training group that later became a company-wide Training & Compliance Group in PV, and developing a company-wide PV onboarding programme. He was the technical lead for training on Oracle ARGUS Safety and Veeva Vault QMS under FDA 21 CFR Part 11, and co-authored the company-wide ARGUS Safety database entry conventions. He also assessed the impact of regulatory changes on the training and qualification of PV staff, and advised business-unit leaders on competency gaps and preventive training programmes.

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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.