Chengxia O'shea
About Chengxia O'shea
Associate Director, Cell Therapy Quality at Bristol Myers Squibb
Chengxia O'shea currently serves as the Associate Director of Cell Therapy Quality at Bristol Myers Squibb. In this role, she leads quality initiatives specifically within the cell therapy domain. Her responsibilities include overseeing compliance with regulatory standards, implementing quality management systems, and ensuring product quality across various stages of development and commercialization.
Previous Roles at Bristol Myers Squibb
Before her current role, Chengxia O'shea held multiple positions at Bristol Myers Squibb. From 2018 to 2020, she worked as the Senior Manager of Quality. Earlier, she served as a Supervisor for Quality Assurance from 2008 to 2009 and as a Scientist and Senior Scientist from 2002 to 2008. These roles helped her develop a robust understanding of quality management, analytical methods, and regulatory compliance.
Quality Management Experience at Top Pharmaceutical Companies
Chengxia O'shea has accumulated extensive experience in quality management through her positions at leading pharmaceutical companies. She worked as a Manager in Quality Analytical at Pfizer in Andover, MA, from 2015 to 2018. From 2012 to 2015, she served as a QC Analyst and later as a Manager in Quality Tech Support at Sanofi Genzyme in MA. Additionally, she was a Quality Manager at Emerson Ecologics in Bedford, NH, from 2009 to 2010.
Educational Background in Analytical Chemistry and Engineering Management
Chengxia O'shea boasts a strong academic background. She earned a Master's Degree in Engineering Management from Tufts University. Additionally, she holds a Master's and Bachelor's Degree in Analytical Chemistry from Nankai University. She also studied Analytical Chemistry at the University of Massachusetts Dartmouth, where she obtained another Master's Degree.
Specializations in Quality Management and Regulatory Compliance
Throughout her career, Chengxia O'shea has specialized in various aspects of quality management and regulatory compliance. She has led the deployment of Laboratory Information Management Systems (LIMS) in new QC organizations and implemented Sample Management and Investigation programs in GMP laboratory startups. Her expertise includes method transfer readiness, lifecycle management of product specifications, managing deviations, conducting root cause analysis, and implementing CAPAs. She has also played a crucial role in leading risk assessments, gap analysis, and remediation to meet regulatory requirements.