Tracy S. Chen
About Tracy S. Chen
Tracy S. Chen serves as the Senior Director of Quality Assurance at Arcus Biosciences, where she has worked since 2020. With a strong background in GMP and GCP compliance, she has held various leadership roles in quality assurance across multiple companies in the biotechnology sector.
Work at Arcus Biosciences
Tracy S. Chen has served as the Senior Director of Quality Assurance at Arcus Biosciences since 2020. In this role, she oversees quality assurance processes and ensures compliance with industry regulations. Her position is based in Hayward, California, where she has contributed to the company's commitment to developing innovative therapies.
Previous Experience in Quality Assurance
Prior to her current role, Tracy held several significant positions in quality assurance. She was the Senior Director of Quality Assurance at Five Prime Therapeutics, Inc. from 2016 to 2019. Additionally, she worked at Anacor Pharmaceuticals as the Director of Quality Assurance from 2011 to 2013 and at Plexxikon Inc. as Director of Quality Assurance from 2014 to 2016. Her experience spans various organizations and includes leadership roles focused on compliance and quality management.
Education and Expertise
Tracy holds a Bachelor of Arts in Biology from the University of California, Berkeley, where she studied from 1988 to 1992. She furthered her education at San Francisco State University, earning an MBA from 2001 to 2003. Additionally, she obtained a Certificate in Clinical Trials Design and Management from the same institution from 2005 to 2006. Her educational background supports her expertise in GMP and GCP compliance, project management, and process improvement.
International Experience in Quality Assurance
Tracy has international experience in the field of quality assurance. She worked as a Site Director for Abbott Medical Optics in Hangzhou, Zhejiang, China, for six months in 2014. This role provided her with a global perspective on quality assurance practices and regulatory compliance.
Career Progression in Quality Assurance
Tracy's career in quality assurance has included various roles that demonstrate her progression in the field. She began as a Senior Manager of Quality Assurance at Alexza Pharmaceuticals from 2007 to 2011, then advanced to Director roles at Anacor Pharmaceuticals and Plexxikon Inc. before taking on senior director positions at Five Prime Therapeutics and Arcus Biosciences. Her extensive experience includes guiding development projects from pre-clinical studies through to market launch.