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Patrick Nieuwenhuizen
Managing Director Consultant
About
Bio
Patrick Nieuwenhuizen is a globally respected specialist in contamination control strategy and EU GMP Annex 1 implementation, with deep expertise in cleanroom compliance and sterile manufacturing environments. He has spent his career working at the intersection of regulatory expectation and practical execution, supporting pharmaceutical and biopharmaceutical organizations in designing, assessing, and strengthening contamination control frameworks that stand up to regulatory scrutiny. His work is closely aligned with Annex 1 principles, cleanroom certification, and risk-based design of sterile facilities.
Patrick is widely trusted as an advisor for inspection readiness, CCS development, and GMP-aligned cleanroom strategy, working with manufacturers to translate regulatory guidance into operationally robust systems. Known for his clarity, precision, and pragmatic approach, he helps organizations move beyond checkbox compliance toward sustainable contamination control embedded into facility design, process flow, and quality culture. His insights are particularly valued by senior quality and engineering leaders navigating evolving global expectations in sterile manufacturing.
Education
Master's Degree , Pharmaceutical Microbiology
The University of Manchester (October 2017 - November 2021)
Professional Background
Managing Director Consultant , Paradigm Pharmaceutical Quality Consultancy
(December 2025 - Present)
Director & Principal Consultant , PharmaLex
Manager - Quality Control , Genzyme, a Sanofi Company
Senior Manager - Quality Control , MedImmune
Awards and Accolades
Active Contributor
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Followers
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Total Articles
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Total Impressions
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