Director, Inspection Program – Quality Operations, Quality Assurance
About me
My professional career spans across various QA and compliance roles within the pharmaceutical industry with responsibilities in the areas of Quality Systems/CAPA management, regulatory intelligence, product complaints, pharmacovigilance and most recently, leading global regulatory inspection readiness and preparation activities (GCP sponsor, PV, GLP, bioanalysis labs and clinical sites).
I started my career in academic research in the areas of Oncology and Immunology. I hold a Bachelor and Master of Science degree in Biochemistry.
In my current role at Astellas, I am responsible for inspection preparation and training, evolution of the Astellas inspection program and providing strategic leadership of global inspection program initiatives.