Linda Zhu is a highly accomplished Director of Quality Assurance at Vaxart, Inc., where she leverages over 15 years of extensive experience in quality, validation, and development within the pharmaceuticals and biotech sectors. Her career spans a diverse range of environments, from dynamic startup biotech...
Linda Zhu is a highly accomplished Director of Quality Assurance at Vaxart, Inc., where she leverages over 15 years of extensive experience in quality, validation, and development within the pharmaceuticals and biotech sectors. Her career spans a diverse range of environments, from dynamic startup biotech companies to leading global pharmaceutical enterprises across the US and Asia. This breadth of experience has equipped Linda with a unique perspective on quality assurance, emphasizing a data-driven approach that aligns with regulatory standards and industry best practices.
At Vaxart, Linda is instrumental in implementing robust quality systems that ensure compliance and oversight of manufacturing and quality control operations. Her role is critical in navigating the complexities of Good Manufacturing Practices (GMP) and adhering to stringent regulations such as 21 CFR Part 11. Linda's expertise in validation processes, Corrective and Preventive Actions (CAPA), and Change Control is vital in maintaining the integrity of biopharmaceutical products throughout their lifecycle.
Currently, she is leading key projects aimed at enhancing operational efficiencies and ensuring that Vaxart's innovative oral vaccine candidates meet the highest quality standards. Her passion for quality is evident in her commitment to fostering a culture of continuous improvement and excellence within her team. As a thought leader in the biotechnology field, Linda actively engages in cross-functional collaborations, driving initiatives that not only comply with regulatory requirements but also enhance product safety and efficacy. Her strategic vision and unwavering dedication to quality make her an invaluable asset to Vaxart and the broader pharmaceutical community.