Rose Lee

Rose Lee serves as the Quality Assurance Regulatory Affairs Manager at Pillar Biosciences Incorporated, with a robust background in quality assurance and regulatory compliance across multiple organizations. With extensive experience managing CAPA, deviations, and eQMS, Rose has also played a critical role in internal audits and ISO 13485 processes. Previous roles include project coordination and support with companies such as Cytonsys Inc., Biogen, and Marigen, where responsibilities encompassed data analysis, compliance with FDA regulations, and project management. An educational foundation in Bioengineering from Rice University and a Bachelor’s degree in Clinical Laboratory Science and Medical Biotechnology from National Taiwan University complements Rose's professional expertise in medical device development and regulatory affairs.