About This Expert

I'm a quality and compliance leader with 12+ years of experience across pharmaceutical, biologics, clinical and medical device environments in three countries. I've led 80+ global supplier qualification audits, managed risk-based internal and external audit programs, and served as the primary quality contact for multiple global contract manufacturers. My expertise covers GMP, GCP and supplier audits, Quality Agreements, CAPA and deviation governance, inspection readiness, and ISO 13485 gap assessments, aligned with FDA, EMA, MHRA and TGA expectations. I hold an MSc in Biopharmaceuticals and am a certified ISO 13485 and ISO 9001 Lead Auditor. I help biotech, pharma and medical device companies build practical, inspection-ready quality systems through remote audits, supplier qualification, SOP and CAPA support, and gap assessments.