Monte Koerner

Background

About Monte Koerner

With over three decades of professional experience, I specialize in quality system compliance within the pharmaceutical and device/combination products industries. Currently serving as Director of QA Vendor Management at Astellas Pharma, I am committed to driving harmonized, global quality solutions that align with the organization's mission of advancing innovative therapies. My collaborative approach ensures streamlined processes that bring diverse perspectives to foster operational excellence. At Astellas Pharma, I have been instrumental in designing and implementing multiple global quality systems. Most recently, I have implemented a global vendor management system using TrackWise Digital, successfully integrating over 1,800 vendors into a unified quality management system. My work reflects expertise in quality system compliance, risk-based auditing, and process harmonization—all critical for maintaining robust operational standards across global teams.