Tamara Ely
FDA - OMQ/OC/CDER
Branch Chief
Tamara Ely holds a master’s degree in Quality Assurance and Regulatory Affairs from Temple University’s School of Pharmacy and a bachelor’s degree in Chemistry from West Virginia University. Since 2015, she continues to support the School of Pharmacy as adjunct associate professor.
Since 2010, Ms. Ely has worked in the Office of Manufacturing Quality in the Center for Drug Evaluation and Research (CDER) reviewing administrative and regulatory actions regarding drug adulteration, evaluating inspectional findings, and determining the acceptability of manufacturing facilities. She also participates in the development of science-based regulatory policy and guidance. In the numerous undisclosed years prior to her joining CDER, she held various quality and compliance positions within the pharmaceutical industry: analytical chemist, certified quality auditor, compliance reviewer, CGMP consultant, and validation consultant.
Since 2010, Ms. Ely has worked in the Office of Manufacturing Quality in the Center for Drug Evaluation and Research (CDER) reviewing administrative and regulatory actions regarding drug adulteration, evaluating inspectional findings, and determining the acceptability of manufacturing facilities. She also participates in the development of science-based regulatory policy and guidance. In the numerous undisclosed years prior to her joining CDER, she held various quality and compliance positions within the pharmaceutical industry: analytical chemist, certified quality auditor, compliance reviewer, CGMP consultant, and validation consultant.