I help life sciences organizations design, build, and govern compliant digital systems — faster and leaner than traditional approaches. With 25+ years across FDA, Health Canada, and EMA-regulated environments, I bring the strategic depth of a senior leader and the agility of a specialist, on demand, without the overhead.

What Sets Me Apart

I'm not a traditional QA or validation consultant. I bring a rare combination of software engineering, global compliance, and business domain expertise — which means I govern and validate systems by actually understanding them: the code, the database architecture, the cloud infrastructure, the AI/ML models. I assure from the inside out — not just the paperwork around it. The result: faster validation, smarter risk decisions, and findings that get resolved, not just documented.