Haifeng Bao
About Haifeng Bao
Haifeng Bao is the Director of Quality Assurance and Risk Management at Brii Biosciences, where he oversees compliance and quality management systems. He has extensive experience in regulatory inspections and has held various roles in quality assurance and clinical research across several prominent pharmaceutical companies.
Work at Brii Biosciences
Haifeng Bao has been serving as the Director of Quality Assurance & Risk Management at Brii Biosciences since 2020. In this role, he is responsible for overseeing the Quality Assurance department and managing a team of two subordinates. His duties include providing Quality Assurance oversight for various GxP vendors and ensuring compliance with regulatory standards. He also communicates audit trending summaries to functional teams to help prevent quality issues and manage risks effectively.
Education and Expertise
Haifeng Bao completed his Bachelor’s degree in Clinical Pharmacy at Xuzhou Medical University from 2005 to 2010. He later studied English as a Second Language at the University of North Carolina at Wilmington for 11 months in 2017. His educational background provides a strong foundation for his expertise in Quality Assurance and Risk Management within the pharmaceutical industry.
Background in Quality Assurance
Haifeng Bao has extensive experience in hosting inspections from the China FDA and EMA, including investigator site audits for Phase I to Phase III Clinical Studies. He is responsible for drafting and updating Standard Operating Procedures (SOPs) to ensure alignment with regulatory requirements and support the maintenance of the Quality Management System (QMS). His role includes acting as an in-house advisor on GxP compliance, providing guidance on regulatory standards such as NMPA, FDA, and ICH.
Previous Work Experience
Before joining Brii Biosciences, Haifeng Bao held several positions in the pharmaceutical industry. He worked as a Senior CRA at Novartis from 2012 to 2014 and as a CRA 2 at GSK from 2011 to 2012, both in Shanghai. He also served as a Senior QA Auditor at IQVIA from 2016 to 2019 and as a Senior Specialist in Medical Standard & QC at Roche from 2014 to 2016. His diverse experience in these roles has contributed to his expertise in Quality Assurance.
Achievements in Quality Management
In his current role and previous positions, Haifeng Bao has been instrumental in providing Quality Assurance oversight for a variety of GxP vendors, including CRO, EDC, and SMO vendors. He ensures their qualification and requalification, which is critical for maintaining compliance and quality in clinical research. His proactive approach in communicating audit trending summaries helps in managing risks and preventing quality issues within the organization.