BUILDING COMPLIANCE PROGRAMS THAT SCALE WITH BUSINESS GROWTH

Matthew Miller

Regulatory, Quality & Operations Leader | Systems Improvement | Enterprise Compliance

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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Executive Career Highlights

Lead enterprise regulatory compliance across four multi-state distribution centers supporting pharmaceutical and medical device operations.
Chair the monthly Compliance Committee, presenting executive reporting and leading discussions on regulatory risk, audit findings, enterprise initiatives, and CAPA strategy.
Led implementation of an enterprise Level 4 DSCSA serialization and traceability solution, establishing scalable controls supporting federal supply-chain security requirements.
Leading enterprise-wide standardization of regulatory classification across an 84,000-SKU healthcare catalog using AI-assisted workflows and FDA data sources to improve accuracy and reduce manual review.
Led successful NABP Drug Distributor Accreditation efforts for Ohio and Texas and established sustainable systems supporting ongoing accreditation readiness.
Direct regulatory inspection and audit strategy across FDA, NABP, and State Boards of Pharmacy, consistently achieving favorable outcomes.
Designed executive Power BI dashboards providing real-time visibility into multi-state licensing, renewal risk, distribution center compliance, and regulatory KPIs.
Built enterprise compliance training and automation workflows using Microsoft Forms, SharePoint, Smartsheet, and Power Automate to strengthen accountability and scale compliance oversight.

Directed plant operations through eight department managers and 83 employees, providing executive leadership across manufacturing, engineering, quality systems, production planning, and regulatory compliance.
Served as Management Representative and second in command to company ownership, aligning quality, operations, and business priorities across the organization.
Led an MDSAP audit as Quality Assurance Manager and was promoted to Plant Manager and Management Representative four months after joining the company.
Modernized the Quality Management System through electronic document management and strengthened ISO 13485 processes, organizational accountability, and audit readiness.
Led a $150,000 manufacturing modernization initiative that reduced lead-pattern cutting time from approximately 40 minutes to 6 minutes per apron.
Established a digital production-planning system to improve leadership visibility into custom manufacturing capacity and order fulfillment.

Led quality-system and manufacturing improvement initiatives supporting ISO 13485 certification and scalable medical device operations.
Designed and established a production laboratory for topical antimicrobial medical devices, integrating facility design, labeling controls, SOPs, process validation, and workforce training.
Improved manufacturing reliability by engineering a centralized purified compressed-air system for PCB cleaning, eliminating process inconsistency and reducing annual operating costs by approximately $10,000.
Established quality testing criteria and production controls supporting negative pressure wound therapy systems.
Led and developed teams across two facilities, standardizing compliant production, testing, and documentation practices.

Directed preclinical regulatory studies supporting IND submissions for biologic and small-molecule development programs.
Coordinated cross-functional study execution, pharmacokinetic analysis, scientific reporting, and outsourced GLP activities to support regulatory development strategy.
Provided governance and scientific oversight of outsourced GLP studies as Study Monitor, aligning CRO execution with regulatory and program expectations.
Presented and defended scientific conclusions supporting regulatory submissions during FDA interactions.
Designed an automated PK/TK reporting solution that improved scientific workflow and earned a Pfizer Achievement Award.

Planned and executed preclinical GLP programs spanning study design, formulations, dosing, sample collection, pharmacokinetic analysis, and regulatory reporting.
Applied pharmacokinetic data and scientific judgment to support compound screening and development candidate selection.
Integrated laboratory execution, data analysis, and scientific reporting to support cross-functional pharmaceutical development programs.

Matthew Miller

Regulatory, Quality & Operations Leader | Systems Improvement | Enterprise Compliance

20+

84,000

4

83

Organizations Served

Signature Projects

Executive Career Highlights

Leadership & Credentials

Military Service

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