Angela Kong

Quality Assurance Manager

Angela Kong is a Quality Assurance leader with extensive experience in the biotechnology and life sciences industry, specializing in GMP quality systems, clinical manufacturing, and regulatory compliance. She has supported biologics, cell and gene therapy, and clinical-stage programs from early development through commercial readiness. Angela has led Quality Management Systems (QMS), supplier qualifications, vendor management, and CMO/CTL oversight, ensuring compliance across outsourced manufacturing, testing, and critical supply chains. Her expertise 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 Phase II biologics manufacturing, 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.