Dr. Claudia Lin is currently the head of Quality Assurance for Global Biologics in Bayer Healthcare, Berkeley. Her group is responsible for all aspects of Quality management for Bayer biotech products in clinical development. Prior to joining Bayer, Claudia held QA and QC positions with increasing responsibilities at Genentech ROCHE Biotech Division in global capacities, such as Clinical Quality Steward, Commercial Analytical Method Transfer, and Annual Product Review. She was instrumental in establishing the Quality Steward function at Genentech as well the process and product quality monitoring systems for ROCHE commercial products. Claudia was a key contributor to the post-approval life cycle management strategy in the filing for Perjeta, a ROCHE biologics developed using QbD principals. Claudia got her Ph.D. in Cell and Molecular Biology from UC Berkeley and has had extensive R&D experience in various therapeutic areas in early part of her career.