Gabriela Gottlieb

Gabriela Gottlieb is an Associate Director of Clinical Quality Assurance at Astellas Pharmaceuticals, where she drives Clinical QA activities related to management of risks, non-compliance and auditing across a therapeutic program to treat Prostate Cancer. In this capacity she interacts with executive level management, external vendors, collaboration partners, clinical study and cross-functional groups to ensure compliance with regulations, Astellas business practices and clinical research program objectives. Prior to Astellas, Gabriela served in a variety of roles in the Medical Device industry in areas of Interventional Oncology, Orthopedics and Interventional Cardiology. She has a track record of implementing quality systems in Clinical Research and Regulatory Affairs. She also has led several regulatory inspections with FDA, EMA and other global regulatory bodies. She bases her approach to program implementation through change management principles with a focus on data integrity, human subject protection and quality.