Laura has 23+ years of Global Quality experience and is a seasoned GxP Quality Professional with 15+ Product Launches for biologics, vaccines, medical devices/combination products. She has worked in Europe for 15+ years including for major pharmaceutical companies Baxter/Baxter Biosciences, J&J (Janssen-Cilag) and SANOFI (Paris) and multiple small companies. She has directed over 60 global regulatory inspections (FDA/EU/RoW, Japan, Notified Bodies-BSI, TUV, etc.) and conducted PAI Readiness Training for over 50 companies.
Laura has experience building and remediating Quality Management Systems for large and small medical device companies, has directed several 13485:2016 certifications for leading companies including FDA Approval for complex products and genomic sequencing (FDA/EU, Canada, Australia and Japan markets), and continues to partner in key consulting firm with former Senior FDA and EU Regulators (pharma/medical device regulatory strategy and routine operations). She’s also part of the European and ISO Working Groups, and CMC Overview including NDAs, BLAs, IDE and PMA quality/regulatory strategies. She has experience authoring SOPs and for large and small clinical/commercial medical device companies, and is a current lead for Major EU MDR Project as Senior Consultant/SME for numerous Technical File updates for a global matrix program (resource/capacity planning, strategic modeling and hands-on review and oversight (partnered with ALKU staffing).