Guang Gao, Ph.D., RAC, CQA

Affiliation:  PATH (US)

Title:      Senior Technical Officer 

Biography (Sentences within 300 Words)

As a senior technical officer at PATH China Office, Dr. Gao is responsible providing stretegic and technical advice to the Center for Vaccine Innovation and Access (CVIA/PATH). Her role in PATH China Office is to provide continued technical support and process guidance to PATH partners in Chna so that these vaccine manufactuers will supply high quality yet affordable vaccines for both domestic and global markets.

Before joining PATH, Dr Gao worked for US FDA (CBER) where she held various positions since 1999, most recently, as Master Reviewer. In that capacity, she served as a national authoritative regulatory review scientist, providing technical leadership and guidance for regulatory activities.  She provided advice on area-specific clinical issues, Good Laboratory Practices (GLP), Current Good Manufacturing Practices (cGMP), and other aspects regulations and compliance, especially as they concern in process testing and assessment of safety and effectiveness.

Dr. Gao was also involved in providing training and consultation to foreign regulators visiting FDA on scientific and regulatory issues.

Dr. Gao worked in US FDA China Office stationed in US Embassy in Beijing as a Drug Analyst. She conducted inspections for drug and device to Chinese firms who export their products to US. During that time, she also provided trainings to Chinese regulators and manufacturers on regulations and compliance.

Guang graduated from Nanjing University. She conducted postdoc trainings a t Dartmouth Medical School and the National Institutes of Health (NIH) in US. She has RAC certification, Drug Investigator certification, and is a Certified Quality Auditor (CQA).  She earned numerous awards from FDA for her contributions.