Over 19 years of experience in Clinical Research & the Pharmaceuticals/Biotech & CRO industry as a seasoned Professional/Executive within Quality Assurance (GxPs), Quality Control (Phase 1 - Phase IV Studies), Global Clinical Site Monitoring, Quality Management Systems (QMS), Computer System Validation, Inspection Readiness, Reg. Affairs/Submission Dossier, PV/Safety Surveillance, Vendor Management & Oversight, Project Management (PM) & as a Sub-Investigator (SI). Summary of Experience:
Currently President/CEO at GG Pharma Consulting, INC. (GGPCI) a Consulting Firm highly specialized in Clinical QA, Global GxP Audits, Quality Control, Site Monitoring, Inspection Readiness etc.). Successfully directed the Global QA & QC program for multiple Therapeutic Areas by applying compliance and risk-based principles (pro-active versus re-active approach) during audits of clinical trials & Quality Control reviews of Clinical Trial related-documents. Have been in charge of the Global Audit program for > than 75 pivotal regulatory submissions from start-to-end resulting in the regulatory approval of several block buster drugs. Subject Matter Expert (SME) in leading Inspection Readiness Activities/Mock Inspections, Sponsor Audits, Internal Audits, Systems Audits, Internal Quality Control reviews, External Audits, Vendor Management/Oversight, Compliance Training and Hosting Regulatory Inspections (> than 160 - Site, Sponsor-Monitor, CRO) by FDA, EMA MHRA, ANMAT etc. Responsible for leading and setting-up the QA department in start-up company & big pharmaceutical firms.
