About Me
My journey began as a QC Inspector in 1970 and has evolved into a specialized consulting practice focused on helping organizations achieve regulatory compliance. I've had the privilege of witnessing and contributing to remarkable advances in quality systems and regulatory compliance across multiple continents.
What drives me is the intersection of technical precision and human collaboration. I've learned that the most successful quality initiatives happen when cross-functional teams are aligned and empowered with the right systems and processes. Whether working with a startup navigating their first FDA inspection or a global organization implementing new quality systems, I'm energized by translating complex regulatory requirements into practical, sustainable solutions.
My international experience across Europe, India, Turkey, and North America has taught me that while regulations may vary, the fundamental principles of quality and safety are universal. I believe in building lasting partnerships with clients, serving not just as a consultant but as a trusted advisor who understands both the technical and business implications of quality decisions.
Career Highlights
Managed quality operations with budgets exceeding $10 million and teams of 150+ professionals.
Achieved exceptional regulatory compliance: zero FDA 483 observations in 13 of 15 inspections.
Successfully led quality initiatives across 9 North American facilities.
Provided consulting services across multiple continents with diverse regulatory frameworks.
Served as interim Head of Quality and Managing Director for client engagements.
Implemented company-wide Lean Six Sigma programs with measurable business impact.
Participated in FDA Supply Chain/Logistics Task Force Committee and industry conferences.