Karen Hirshfield, Director, Enterprise Regulatory Compliance, Johnson & Johnson, performs assessments of quality and compliance risks for external CGMP audits and global health authority requirements. She previously worked for Genentech-Roche as a Principal Compliance Specialist. Karen worked for 24 years as a Pharmacist in the US Public Health Service, where she reached the rank of Captain. Most of her career was spent with the FDA. She completed her FDA career as the Deputy Director, Division of Domestic Field Investigations, Office of Regulatory Affairs. She holds a BS in pharmacy from the University of New Mexico. She has been an ISPE member since 2015.