BUILDING COMPLIANCE PROGRAMS THAT SCALE WITH BUSINESS GROWTH

Matthew Miller

Regulatory Compliance Leader | DSCSA | Medical Devices | Distribution Licensing

Regulatory compliance executive with 20+ years of experience spanning pharmaceutical research, medical device manufacturing, pharmaceutical distribution, quality systems, and FDA-regulated operations.

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Career Highlights

Implemented DSCSA traceability solution (RFXCEL)
Achieved NABP Drug Distributor Accreditation for Ohio and Texas facilities
Classified 84,000 healthcare products and automated compliance controls
Led FDA, NABP, and Board of Pharmacy audits across multiple distribution centers
Presented compliance metrics, risks, and strategic initiatives to Executive Leadership monthly
Created Power BI Dashboard to provide multiple KPIs and a real-time view into our licensing portfolio by license type, distribution center, and renewal due dates
Delivered hands-on compliance training across four distribution centers

Led MDSAP audit
Managed 83 employees
Implemented QDMS document management
Deployed $150,000 CNC modernization project

Achieved ISO 13485 certification
Built production laboratory
Created SOPs and training programs
Established all QA testing criteria for Negative Pressure Wound Therapy pumps
Managed staff across facilities

Independent contributor to IND submissions for biologic and small-molecule development programs
Led preclinical studies from design through WinNonlin analysis and regulatory reporting
Study Monitor overseeing outsourced GLP studies at CROs
Defended scientific conclusions during FDA reviewer interactions
Pfizer Achievement Award recipient

PK/TK analysis
Regulatory research
Product development support

Matthew Miller

Regulatory Compliance Leader | DSCSA | Medical Devices | Distribution Licensing

20+

84,000

4

83

Organizations Served

Signature Projects

Career Highlights

Leadership & Credentials

Military Service

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