Matthew Smith

About Matthew Smith

As a senior QA/RA executive with 17+ years leading biologics and healthcare operations, I specialize in guiding companies through complex FDA and international regulatory approvals—delivering compliance, scalability, and revenue growth.Key Highlights: Led FDA BLA approval and international certifications (MFDS, AGES, GHA, IQPP) Built global QMS infrastructure from the ground up Directed lean process initiatives contributing to 9-figure revenue growth Drove $100M+ in annual B2B partnerships across US, EU, and AsiaLet’s connect if you\'re scaling a biotech operation or navigating global regulatory hurdles.At Olgam Life, I lead transformative initiatives across Quality Assurance and Regulatory Affairs that have elevated our biologics manufacturing capabilities and ensured seamless regulatory compliance—domestically and internationally.In my current role as Head of Quality and Regulatory Affairs, I’ve built and led world-class teams that implemented scalable quality systems (QMS), secured FDA Biologics License Application (BLA) approval, and achieved compliance with European and Asian regulatory bodies.

Experience

1. Head of Quality Assurance and Regulatory Affairs

   Olgam Life

   Apr 2023 — Present · New York, NY, US

   Led all regulatory and quality departments for a new biologics manufacturing company. Achieved significant regulatory milestones through leading the company’s development of all critical QA functions to include; development of Standard Operating Procedures, Quality Systems, QMS, management of all Biologics Licensing Applications activities, and international regulatory approvals in Asia and Europe.

Education

• Grand Canyon University

  Master of Business Administration (M.B.A.)

• Grand Canyon University

  Bachelor of Science - BS, Business Administration and Management, General

Skills

• Administration
• Team Leadership
• Training
• Leadership Development
• Financial Analysis
• Human Resources
• Operations Management
• Customer Service
• Hiring