William Mestrandrea

About William Mestrandrea

At Bristol Myers Squibb, leadership in quality and compliance is my arena, where I have honed my expertise in quality systems design, inspection readiness and quality auditing. The value I bring encompasses leading a cross-functional, global team, providing strategic oversight of our audit, inspection readiness, and regulatory compliance programs, ensuring our global quality management system remains robust and compliant with ever-evolving regulations. My role in fostering an inclusive environment has not only increased colleague performance but also heightened engagement. Collaborating closely with stakeholders, my focus is on enabling success and maintaining the highest standards of quality in our products, ensuring the health and safety of patients worldwide. In my current role as the Executive Director of Competitive Quality, I provide strategic and tactical direction for the GPS divisional audit program for product development, clinical supplies, manufacturing, and product distribution across all modalities. I lead inspectional readiness activities across the network inclusive of biologics, small molecule, and cell therapy as well as distributors and local markets inclusive of global regulatory agencies worldwide. I serve as consultancy to sites/functions with regulatory inspections including pre-inspection readiness as well as regulatory inspection responses for complex compliance maters. I assist with regulatory notifications, including assuring appropriate and consistent standards are in place, and in the development of global training programs on quality processes and procedures.

Experience

1. Head of Gmp Gdp Audit, Inspection Commercial

   Sanofi Us

   Jun 2025 — Present · Morristown, NJ, US

Education

• Brooklyn College

  B.S.

  1987 — 1992

• Stevens Institute of Technology

  Masters of Business Administration

  2013 — 2018