Karen Hirshfield, RPh, is Director, Enterprise Regulatory Compliance, for Johnson & Johnson. Karen performs assessments of quality and compliance risks for external GMP audits and global health authority requirements. She joined Johnson & Johnson from Genentech-Roche, where she served as a Principal Compliance Specialist in the Global Quality Compliance and External Collaboration group. 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 with the FDA. She completed her FDA career as the Deputy Director, Division of Domestic Field Investigations, Office of Regulatory Affairs. She is a licensed pharmacist and holds a BS in pharmacy from the University of New Mexico. She has been an ISPE member since 2015.