Carol (Rehkopf) Cirigliano, MS, Reg. Sci., MBA
Strategic biopharmaceutical professional & Retired FDA Senior Leader. Multifaceted leader with well-rounded medical product regulatory experience with biologics, drugs, and devices.
Daiichi Sankyo US•Global
View LinkedIn ProfileExperience35+ Years
LevelCXO
Executive Overview
Retired FDA senior leader providing strategic direction for policy, regulatory, quality, and biopharma compliance operations, regarding drugs, biologics, devices and combination products. Always leading through the gray areas to provide meaningful products to patients. Specialties: Policy, Strategy, Regulatory, Quality, CMC, GMP, Organizational Leadership, and Change Management
Career Timeline
- Daiichi Sankyo USCurrentSep 2023–Present· 3 yrs
- Executive Director, Quality Assurance ComplianceCurrentSep 2023–Present
- 2022–Sep 2023· 1 yr 8 mos
- Global Quality and Compliance2022–Sep 2023
- 2008–Sep 2009· 1 yr 8 mos
- Supervisor, Quality Systems Audits2008–Sep 2009
- 1991–Dec 2021· 30 yrs 11 mos
- Deputy Associate Director, Senior Leader, Review Management, CBER Immediate Office of the DirectorJul 1991–Dec 2021
- Reviewer, Inspector, Consumer Safety Officer1991–2008
Education
Certificate of Mastery
Leadership for a Democratic Society
Federal Executive Institute
Master of Science - MS
Regulatory Science
University of Maryland School of Pharmacy
Masters Certificate
Project Management
University of Pittsburgh Katz Graduate School of Business
Bachelor
Legal Studies/Biology
University of Maryland Global CampusExecutive Relationship Map
Reports To
Carol (Rehkopf) Cirigliano, MS, Reg. Sci., MBA
Vice Chair & President
Chief Financial Officer
Chief Technology Officer
Chief Operating Officer
Skills & Expertise
DevceISO 13485Quality SystemsDrugsComplianceRegulatory AffairsRisk-Based Inspection (RBI)SopHealth PolicyStrategic PlanningStrategic PartnershipsMedical DevicesPICSValidationBiologicsAuditingRegulatory ComplianceBiotechnologyQuality AuditingCombination Products