Jamie Jamshidi is a Quality Unit (QU) and Regulatory Operations (RO) professional with over 34 years of industry experience, including small molecules, large molecule biologicals and peptides. Jamie experience gained working in the US, EU & Asia in site and corporate roles. Jamie has held leadership roles in Quality Unit (QU) and Regulatory Operations (RO) throughout product lifecycle.

She retired from Amgen, Inc., in 2007 after 17 years of service with the company. Some of Jamie’s major accomplishments include assisting with launching Amgen, Inc.’s first three commercial products and start up facilities globally. Jamie was the key Quality Assurance (QA) representative at several FDA and other regulatory inspections at contract manufacturing sites. She has extensive knowledge and expertise in the areas of product regulations, Quality Management System (QMS), Quality Unit (Quality Assurance and Quality Control), CMC Manufacturing, Validation, Analytical Labs, Regulatory Submissions, Regulatory Inspections (PAI), Project Management, Outsourced Activities, Managing Contract Manufacturing, Technology Transfer, Audits, and Team Leadership.

In March 2007 and later in 2011 she formed two consulting firms providing expert technical services, solutions, and training to pharmaceutical and biopharmaceutical companies worldwide.

Since Oct 2014, Jamie has been working with over 15 Startup companies assisting them with providing Quality and Regulatory Consulting. The key Consulting services including, support clients during all stages of a product’s lifecycle from discovery to commercialization, acting Head of Quality Unit (QU) and Regulatory Operation (RO), and Chief Compliance Officer (CCO) for start-up companies, oversee the establishment, maintenance, and implementation of Quality infrastructure, system, and procedures, including non-clinical, clinical, and commercialization.

Jamie has studied pharmaceutical and Biotechnology regulations for over 34 years and has given numerous lectures and talks in the areas of Quality and Regulatory in several colleges, universities, and conferences globally. She is well known in bio/pharmaceutical industry for her passion and respect for FDA and international laws and regulations.