Jamie Jamshidi

Jamie Jamshidi is a quality and regulatory operations expert with over 35 years of experience in the biotech and pharmaceutical industry, specializing in GxP compliance, Quality Management Systems, and regulatory affairs across the full product lifecycle. Since 2014, she has served as founder and principal of GxP Council, Inc., where she acts as interim Head of Quality Unit, Regulatory Operations Lead, and Chief Compliance Officer for start-up companies, supporting clients from pre-clinical development through market launch and commercialization. Her career includes a decade as Vice President of Quality and Regulatory Affairs at Karyopharm Therapeutics, where she built the QA/QC and regulatory infrastructure from the ground up, oversaw global regulatory filings (EU, Canada, USA), and managed NDA/MAA submissions. Prior to Karyopharm, she was CEO and President of Quality & Regulatory Management (QRM) and PQC Bioscience, Inc., providing consulting services to pharmaceutical and biotech start-ups. She spent 18 years at Amgen, where she held progressive roles in Quality Assurance — including QA Supervisor in Microbiology, QA Auditor, Compliance Team Leader in Clinical Manufacturing, and Senior Manager of Small Molecule Quality — and contributed to the launch of Amgen's first two commercial products, Epogen® and Neupogen®, and the approval of Sensipar®.

Jamie is a recognized speaker and trainer on GxP quality systems, clinical trial quality, FDA inspection preparation, and QU roles and responsibilities. She holds certifications in pharmaceutical education, quality auditing, and analytical method validation.