Kevin Shea – US Practice Lead
Kevin brings more than 25 years of experience at the intersection of technology, compliance, quality, and strategy in the life sciences. He works with pharmaceutical manufacturers, biotechnology companies, software vendors, and CROs — both as a strategist and as an embedded practitioner.
His core expertise spans computer system validation (CSV), GxP compliance, AI governance in regulated environments, and technical due diligence for M&A transactions. He currently serves as Fractional Head of Quality at CellPort Software and sits on the advisory board of Valkit.ai.
Kevin’s approach is evaluative, not prescriptive. He assesses where an organization is — documentation, processes, evidence — then helps close gaps incrementally, adapting to operational context rather than applying generic frameworks.
He writes about AI validation, supplier management, and compliance strategy at driftpin.substack.com.
Areas of Focus
- Computer System Validation — FDA and EU Annex 11 frameworks
- AI governance and validation readiness for regulated environments
- EU regulatory bridging — FDA to EMA transition
- Technical due diligence for life sciences M&A
- Fractional Head of Quality / VP Quality engagements
- Supplier qualification and audit support