Michelle McGuinness, MS

Michelle McGuinness is a strategic Life Sciences leader with more than 25 years of experience across Regulatory Affairs, Quality Assurance, and Compliance for small molecules and biologics. She has guided programs from pre-IND/CTA through post-approval across neuroscience, oncology, immunology, rare disease, and drug-device combination products. Her track record includes securing Orphan Drug, Fast Track, and Rare Pediatric Disease Designations, driving 505(b)(2) strategies, leading FDA and EMA engagements, and advancing rolling sNDAs through to approval and exclusivity.

On the Quality and Compliance side, Michelle has served as Head of QA for multiple clinical-stage companies, hosted FDA inspections without significant findings, and acted as Data Protection Officer for multi-region GDPR compliance. Her executive roles include Senior Director of Compliance Operations at AstraZeneca, Head of Compliance Strategy & Analytics at Janssen, and VP of Global Regulatory Affairs & Quality Assurance at Veloxis Pharmaceuticals. At Mylan, she led a crisis remediation — auditing over 10,000 export dossiers in 180 days — that prevented an estimated $1 billion in potential losses.

Michelle holds an MS in Quality Assurance & Regulatory Affairs from Temple University, completed doctoral coursework in Regulatory Sciences at USC, and serves on boards and advisory committees for Prostate Cancer Research US, CureCADASIL, and the CADASIL Consortium.