Angela Kong

Quality Assurance Manager

Angela Kong is a Quality Assurance leader with more than 18 years of experience in the biotechnology and life sciences industry, specializing in GMP quality systems, clinical manufacturing, and regulatory compliance. She has extensive expertise supporting biologics, cell and gene therapy, and clinical-stage programs from early development through commercial readiness. Angela has led Quality Management Systems (QMS), supplier qualification, vendor management, and CMO/CTL oversight, ensuring compliance across outsourced manufacturing, testing, and critical supply chains. Her experience includes managing deviations, CAPA, change control, internal audits, inspection readiness, and cross-functional partnerships with Manufacturing, QC, CMC, and Regulatory Affairs. She has supported global regulatory submissions and inspections, including BLA, NDA, PMA, 510(k), and pre-approval activities. Currently leading Quality initiatives for Centivax, Angela focuses on building scalable, risk-based quality systems that meet FDA, ICH, and GMP requirements while enabling efficient product development. She holds a Bachelor of Arts in Molecular and Cell Biology from the University of California, Berkeley, and is passionate about advancing quality culture and protecting patient safety.