Omschrijving

If you are bringing AI into a regulated environment, or your validation has outgrown its old document-heavy model, I help you move forward without losing the trust of an inspector.

I am a senior pharma quality IT and validation advisor with 25 years in the industry and nearly 20 in CSV. I help regulated manufacturers and life sciences software vendors move from heavy CSV to risk-based CSA, take validation paperless, modernize enterprise quality systems (eQMS and QMS 2.0), and validate AI and ML for GxP. Across three global organizations I have held a record of zero critical findings over 300+ inspections (FDA, EMA, PMDA, WHO, TGA, ANVISA), and I took AI through FDA and MHRA inspection with zero observations.

I created the DRIVE framework for the CSV to CSA shift and DiVAL for paperless validation, contribute to EU GMP Annex 22 (AI), serve on the Global GAMP Steering Committee, and wrote Validating AI in GxP: A Practitioner's Guide.

Typical engagements: AI-in-GxP validation readiness reviews, CSA transition diagnostics, paperless validation and QMS modernization, data integrity and 21 CFR Part 11 health checks, and fractional compliance advisory. I work remotely worldwide and am glad to start with a short scoping call.

Branche-expertise

Talen

Engels
Tweetalig / moedertaal

Voorkeuren voor werkplek

Kan op locatie werken

Brussels (tot 50km)

TrustBridge Compliance
Founder & Principal Advisor
januari 2026 - Vandaag (7 maanden)
India
• • Practice. Advisory practice for digital quality transformation and AI-in-GxP governance across pharma, biotech, and CDMO. Engagements span AI-in-GxP validation readiness reviews, CSA transition diagnostics (DRIVE), paperless validation and QMS modernization, data integrity and Part 11 health checks, and fractional compliance leadership. Authority. Author of Validating AI in GxP: A Practitioner's Guide (2026), with the companion AI Validation Cookbook series and the 'Trends in CSV(A)' newsleter (16,700+ subscribers).
UCB Pharma
Global Head, Quality Digital Industrialization | Business Process Owner, Quality IT
juni 2025 - april 2026 (10 maanden)
Brussels, Belgium
Business Process Owner for global Quality IT, governing EUR 16M annual investment and a EUR 45M digital quality portfolio. Led the global Veeva Quality Suite rollout to 15,000+ users and architected the Pharma 4.0 quality data platform. Conceived and deployed validated, inspection-ready AI tools within GxP processes (DAVE for deviation authoring, Investigative Ingrid for root cause, Query Qinn, AI-assisted CAPA, predictive quality KPIs) and the enterprise AI governance framework, with zero Health Authority observations to date.
Boehringer Ingelheim
Global Head, Quality Digitalization & Validation (CSV, CSA & Equipment Qualification)
januari 2023 - mei 2025 (2 jaren en 4 maanden)
• • Promoted to Global Head, Equipment Qualification & CSV (Jan to May 2025) from Head of CSV & Qualification Standards (Jan 2023 to Dec 2024), with full accountability for CSV/CSA strategy, governance, and standardization across global manufacturing.
• • Designed and led DiVAL, the enterprise transition from traditional CSV to Computer Software Assurance, aligned to GAMP 5 2nd Edition, EU GMP Annex 11, and 21 CFR Part 11 across 15+ global manufacturing sites, with a risk based, AI-ready governance model that replaced fragmented site practices.
• • Built the global CSV/CSA governance framework from the ground up: lifecycle standards, risk-based validation models, and harmonized documentation for cloud, SaaS, and on-premise systems, architected to extend to AI enabled system validation.
• • Introduced Modular Qualification Architecture across global manufacturing, reducing equipment qualification cycle times by 45% and generating EUR 10M+ in annual savings, subsequently adopted as the enterprise standard.