Vice President, Quality Assurance/Regulatory Affairs
Kathy Williams joined RoosterBio Inc. as Director, Quality Assurance in January 2017. She is responsible for providing strategic direction for the company’s quality operations including development, implementation, and maintenance of the Quality Management System in accordance with appropriate regulatory requirements.
Kathy has more than 20 years of GxP industry experience, including over 13 years in quality assurance. In her previous role as Associate Director, QA Operations, Novavax Inc., she was responsible for ensuring cGMP compliance of all clinical product production at two manufacturing facilities and multiple contract manufacturing organizations. Prior to that, as QA Manager at Leidos Biomedical Research Inc. (formerly SAIC-Frederick), she was responsible for managing QA lot release, compliance and training.
Kathy received her Bachelor of Science degree from the University of Maryland and earned a Master of Science degree in Biotechnology from Johns Hopkins University.