Karen Hirshfield is a Senior Compliance Specialist in the Global Compliance and External Collaboration group, for Genentech, Inc. In this position, she is responsible for providing objective and uniform assessments of quality and compliance risks for internal GMP audits and global health authority requirements. She also interacts with external industry groups to provide input on technical quality issues through articles, speeches and participation on committees.
Prior to joining Genentech, Karen worked for the US Public Health Service (USPHS) as a nuclear pharmacist at the National Institutes of Health and in various positions within the US Food and Drug Administration including Field Investigator, CDER Compliance Officer, Acting Team Leader and Branch Chief for CDER’s Recalls and Shortages Branch, and as the Deputy Director of the Division of Domestic Field Investigations within the Office of Regulatory Affairs. Karen received her BS in Pharmacy from the University of New Mexico. In 2012, after 24 years of service, she retired from the USPHS having achieved the rank of Captain.