Loreena Sadowski Email & Phone Number

I lead a global Inspection Management team that prepares and manages GCP inspections across all therapeutic areas and regulatory agencies. My team also works with process owners and operational leaders to optimize processes that support successful inspections, ensuring our medicines reach our patients timely. My pharmaceutical development career journey started over 20 years ago when I took the opportunity leap from nursing into clinical research as a research nurse in acute stroke. Here, I realized the fulfillment of being a part of discoveries that give patients new leases on life and this drove me to learn more about clinical research where I then became a clinical research monitor in Canada. Realizing the impact quality of clinical research can have on patients I moved to the quality organization where I led system, vendor, and site audits and eventually managed several FDA, EMA, and Health Canada inspections. Prior to my current role in Inspection Management, I was the Head of the Americas Regional Clinical Compliance organization who was responsible for development and implementation of risk-based, quality-by-design clinical compliance program that met internal and external stakeholder needs while maintaining inspection readiness. My career journey has provided me the opportunity to experience end to end development processes and I have a passion for finding practical, effective, process solutions that assure quality and compliance. My role now as the head of Inspection Management allows me to share the impact of day to day quality work and influence process change that supports successful inspections that lead to approval of new therapies for our patients. I have a Bachelor of Science in Nursing and a Masters in Regulatory Sciences and Quality Assurance.