← Back to Team
Lead Compliance Architect & Officer
Jasper Donkers
“If you can’t explain it in simple terms, you do not understand it well enough.”
IEC 6244321 CFR Part 11EU GMP Annex 1
“If you can’t explain it in simple terms, you do not understand it well enough.”
“If you can’t explain it in simple terms, you do not understand it well enough.”
Jasper architects compliance into validated mission-critical systems. He leads compliance strategy across DCC’s pharmaceutical, biotech, and critical infrastructure engagements — translating regulatory frameworks (EU GMP Annex 1, 21 CFR Part 11, IEC 62443) into working systems, not paper.
He visualises and explains the overall context for cross-functional teams to increase their motivation and to enlarge the team’s attention to both the big picture and the essential details. This action-based approach, looking through the customer’s eyes, creates a high level of ownership and quality for the digital products he delivers.
Jasper’s experience includes managing the onboarding and intake process for new customers and applications for the DCC team, taking responsibility for digital product development with international teams for a leader in academic publishing, and defining, managing, and validating the quality management system and laboratory information system in a Good Manufacturing Practices (GMP) company. His current engagements include NecstGen (cell & gene therapy CDMO) and WQA (US water quality testing), where he designs and delivers validated Digital HUBs end-to-end — from regulatory scoping and quality system design through user interface and operational rollout.
With a background in literature, philosophy, and political science, Jasper goes beyond the familiar to the inside-out in order to frame the right questions and create new ways of working together. His professional curiosity is best demonstrated in product design workshops, where he translates complexity into understandable language for everyone involved in the decision-making process. Systems thinking — Perrow, Meadows, Hollnagel, Scott, Dekker — anchors a practice oriented toward operational resilience under high stakes.
Jasper writes monthly at HiddenCove — theory and literature, read together, from inside regulated systems. Currently pursuing CISM certification.
Jasper also writes on systems thinking and operational resilience at HiddenCove.
Talk to us about your specific challenge — no pitch decks, just a direct conversation.
Schedule a conversation
