Regulatory Compliance Leader | DSCSA | Medical Devices | Distribution Licensing
20+ years of experience spanning pharmaceutical research, medical device manufacturing, quality systems, regulatory compliance, and distribution operations.
I began my career in pharmaceutical research before transitioning into medical devices, quality systems, manufacturing leadership, and regulatory compliance. Throughout my career I have led teams, managed manufacturing operations, implemented compliance programs, and supported organizations through complex regulatory requirements. Today I focus on pharmaceutical distribution compliance, DSCSA implementation, multi-state licensing, audit readiness, and operational controls.
Current Focus
• Pharmaceutical Distribution Compliance
• DSCSA Traceability Programs
• Multi-State Licensing
• Medical Device Distribution Controls
• Audit Readiness & Accreditation
• Regulatory Risk Management
Organizations Served
Pfizer
Procter & Gamble
Boxout
U.S. Army
University of Toledo
Career Highlights
Boxout – Regulatory Compliance Manager
Compliance oversight for four distribution centers, DSCSA implementation, NABP accreditation, and leadership of the 84,000 SKU product-classification initiative.
Wolf X-Ray – Plant Manager / Quality Assurance Manager
Led MDSAP audits, served as Management Representative, managed 83 employees, and modernized manufacturing operations.
Pfizer – Regulatory Affairs Scientist
Managed preclinical regulatory studies supporting IND submissions, served as Study Monitor for outsourced GLP studies, and received the Pfizer Achievement Award.
Procter & Gamble – Regulatory Affairs Scientist
Conducted GLP studies, PK/TK analysis, and candidate evaluation supporting product development programs.
Education
University of Toledo
Bachelor of Science, Pharmacology & Toxicology
Certifications & Credentials
Ohio Notary Public Commission
Ohio Remote Online Notary Authorization
ISO 13485:2016 Quality Systems
MDSAP Audit Leadership
HIPAA & Data Privacy Compliance
Awards & Recognition
Pfizer Achievement Award
Army Commendation Medal
Five Army Achievement Medals
Good Conduct Medal
Overseas Service Ribbon
Korean Defense Service Medal
Professional Leadership
Board Member, University of Toledo Alumni Association. Supports alumni engagement, scholarship reviews, fundraising initiatives, and community outreach.
Areas of Expertise
DSCSA Compliance • Multi-State Licensing • Internal & External Audits • GDP • GMP • GLP • ICH • ISO 13485:2016 • Project Management • Risk Assessment & Risk Management • HIPAA & Data Privacy Compliance • Medical Device Compliance • FDA Compliance
