Seasoned Quality Leader

Pharmaceutical/Biologics Principal Consultant with hands-on experience in (GCP, GLP & GMP), Quality, Manufacturing & Regulatory Compliance (Remediation/Certification of Manufacturing sites for SVP-TS/LVP/Aseptic), Vaccines (including Covid-19 DS/DP Manufacturing, Interim Controls & Inspection Readiness mentoring), Monoclonal manufacturing, Gene Therapy, International Audits, API Manufacturing, Technology Transfers, Compliance Training, and overseeing Contract Manufacturing Organization responsibilities internationally.

Relevant Therapeutic Areas

  • Oncology
  • Rare diseases
  • Vaccines
  • Infectious diseases
  • Immunology
  • Inflammation
  • Hematology
  • GI
  • Endocrinology
  • ENT

Product Technologies

  • Gene Therapy
  • Monoclonal Antibody & ADCs
  • DNA & RNA Therapeutics
  • Biologics
  • Small Molecules
  • Cell Therapy
  • Diagnostics

Recent Titles

  • Head of Quality Control
  • Associate Director, Quality


  • California
  • Open to remote and travel

Relevant Companies

  • Alexion
  • Fresenius
  • Novartis
  • Small & Mid-Sized Biotechs

Skills & Accomplishments

  • Successful EUA for Covid-19 Vaccine for a client.
  • Zero observation by FDA in Quality Related Inspection at a client site for Aseptic Manufacturing of Oncolytic Product.
  • 9 INDs and 18 NDAs for Biotech/Pharmaceutical Companies.
  • Well over 270 audits for clients in Biopharma/Pharma/CMO and CTL client sites (for Inspection Readiness, for Cause, Supplier Qualification, Remediation base-line audits etc.).
  • 27 Test Method Transfers (Globally for Biotech & Pharmaceutical clients including vaccine, monoclonal and APIs (DS/DP).