Kathy oversees the daily operations of the Quality Assurance and Quality Control Organizations in the US. Kathy has more than 30 years of experience in Quality for both clinical and commercial manufacturing. Her primary experience is in biologics but also has experience in cell therapy and combination products.
As Vice President of Quality at RoslinCT USA (formerly Lykan Bioscience), Kathy’s global agency experience includes US, EMA and TGA as well as other international agency experience. She has hosted both pre-approval inspections as well as routine GMP inspections. Kathy is committed to establishing a strong Quality Culture and efficient Quality Management System while embracing data-driven risk assessments and continuous improvement.
Prior to joining RoslinCT, Kathy held various leadership roles in Quality at Alexion, Shire, Lonza, Biovest International, and Q-One Biotech.