What I’m focused on right now

Career focus

  • Director / Sr Director roles in GCP & GxP Quality Systems / Quality Operations
  • Select implementation and launch roles in healthcare AI / tech (governance + operating model + execution)
  • High-leverage consulting projects where I can deliver clear outcomes quickly

Writing focus

I’m building a practical library of posts that go beyond “hot takes” and into real execution — tools, patterns, and examples teams can actually use.

AI governance and quality oversight

  • Monitoring, drift, and performance management
  • Validation approach and documentation strategy
  • Data governance and traceability
  • Scaling oversight and audit readiness

QbD and lifecycle quality

  • Control strategy and risk-based thinking
  • DOE and knowledge management
  • CPV and data integrity
  • Tech transfer and lifecycle management

Operational excellence in GMP environments

  • Flow, WIP limits, and practical boards
  • Risk-based validation and right-sized documentation
  • Training effectiveness and CAPA prevention
  • Leadership reporting and audit-friendly metrics

How to use this site

If you’re dealing with a quality systems or inspection readiness problem, start with the Blog and look for:

  • checklists
  • templates
  • evidence strategy and examples
  • common failure modes and how to avoid them

Last updated: 2025-12-29