Denise DiGiulio Genentech

Denise DiGiulio is the head of the global audit program and inspection mangement at Genentech / Roche. She is responsible for ensuring site readiness for inspections, audit program strategy and execution, and conformance to regulatory expectations including inspection preparation & response management, global auditor certification management, PAI inspection readiness, and remediation program management. Prior to Genentech / Roche she worked at Johnson & Johnson leading a team responsible for compliance support, policy, and risk management after a twenty-year career with the U.S. Food and Drug Administration where she held roles as ORA field investigatior, and in CDER as a compliance officer and process/facility assessor. While at FDA Denise was a consistent leader in the modernization of FDA’s training, regulations, and inspection procedures and worked on initiatives to integrate drug application review and facility inspection and to increase the effectiveness of pre-approval inspections. Denise received her BS in pharmacy from Rutgers College of Pharmacy and is a registered pharmacist in NJ.