Seasoned Quality Leader

25+ years in the industry with 20+ years of cGMP Biotechnology experience (12 years managing FTEs) in QA, QC, global commercial and clinical fields. Expertise also extends to project management SME / Leadership, business process improvement lead, gene therapy, monoclonal, small molecule, device, global quality technology transfer lead, international market launch, QMS SME / PAI readiness lead, risk assessment lead, and Quality Regulatory Lead responsibilities.

Relevant Therapeutic Areas

  • Rare diseases
  • Infectious diseases
  • Hematology

Product Technologies

  • Gene Therapy
  • Monoclonal Antibody
  • Small Molecules
  • Medical Devices

Recent Titles

  • Director of Gene Therapy QC
  • Global Head of Method Monitoring
  • Sr. Manager, Global Quality


  • Southeast Region
  • Open to remote and travel

Relevant Companies

  • BioMarin
  • Roche
  • Small & Mid-Sized Biotechs

Skills & Accomplishments

  • Head of Quality /QC, Clinical QMS implementation SME, Risk Assessment SME
  • Seasoned and Focused, creative leader / SME for new and existing site/global quality functions
  • Worked in clinical to commercial drug launch for monoclonal, device and gene therapy companies with the responsibility of regulatory filings for Quality
  • As the Quality lead for major drug product launches, had the role of managing direct report and managing other SMEs and leads as well as collaborating with manufacturing and regulatory for a successful filing