Sahar Wazen

Sahar Wazen has over 25 years of experience in the Quality Assurance field. Sahar began their career in 1996 at Schering-Plough as a Stability Coordinator, where they managed the product stability program, including calibration, validation and environmental monitoring of Stability Chambers. In 1999, they moved to Rexall Sundown as a Quality Specialist. In 2003, they joined Schering Pharmaceuticals as a QC Project Coordinator, where they determined regulatory strategy for Product Transfers and monitored projects through completion. In 2010, they joined Merck as a Senior Quality Specialist, where they supported Merck Global Regulatory Group in preparing and submitting requested declarations and registration documentation updates for emerging markets, managed Annual Product Review process for drug products manufactured and packaged at the Miami Lakes site, and reviewed documentation and supporting data for NDA eCTD compilation and Annual Regulatory submissions. In 2017, they joined TherapeuticsMD as a Quality Assurance Manager, where they were the Project Manager for Veeva QMS implementation and developed and delivered training curriculum for the QMS processes of Change Controls, Deviations, Investigations and CAPAs. In 2019, they joined Aurinia Pharmaceuticals Inc. as GMP QA Manager. Currently, they are a Senior Quality Management System (QMS) Manager at Imago BioSciences, Inc.

Sahar Wazen earned a BS in Chemical Engineering from the University at Buffalo from 1988 to 1990. Sahar then went on to receive an MBA in Global Management from the University of Phoenix from 2001 to 2004. In December 2017, they obtained a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS).