17 May Elizabeth Leininger, Ph.D.
Dr. Leininger is an expert in regulatory affairs and quality, with more than 20 years of experience at CBER/FDA and at biopharmaceutical companies. She previously held senior management positions at Chiron (acquired by Novartis) and GSK. Additionally, she has significant expertise in global strategic development, licensing and post-marketing regulatory activities for biological and biotechnology products. She also ran large QA/QC organizations responsible for the evaluation, development and implementation of Quality Systems, including documentation, training and auditing. Dr. Leininger earned her Ph.D. in chemistry from the University of North Carolina at Chapel Hill.