Jamileh (aka 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's experience gained working in the US, EU & Asia in site and corporate roles. Jamie has held leadership roles in the Quality Unit (QU) and Regulatory Operations (RO) throughout the 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 two commercial products, Epogen® and Neupogen®. Jamie was a key team member in the start-up of numerous new Amgen CGMP facilities in the U.S., Puerto Rico, and Europe. She helped establish several new departments at Amgen, including Contract Manufacturing and Small Molecule Quality Unit (QU). She was also instrumental in helping Amgen obtain approval for their first small molecule product, Sensipar®. Jamie was the key Amgen Quality Assurance (QA) representative at several FDA and other regulatory inspections at contract manufacturing sites.

In March 2007 Jamie started PQC Consulting, Inc., and later in 2011, the Quality and Regulatory Management (QMR) consulting firm providing expert technical services, solutions, and training to pharmaceutical and biopharmaceutical companies worldwide. In January 2011 she was the Head of Training and Education for the BioScience Alliance (BSA) and the Head of the Quality Unit (QU) with Karyopharm Therapeutics. From September 2011 to Oct 2014, she was the Vice President (VP) of Quality and Regulatory Affairs, and the Quality & Regulatory Advisor at Karyopharm Therapeutics, Inc.

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, overseeing the establishment, maintenance, and implementation of Quality infrastructure, system, and procedures, including non-clinical, clinical, and commercialization.

She has extensive knowledge and expertise in the areas of product regulations, Quality Management Systems (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.

Jamie is the FDA subject matter expert (SME) that 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 the bio/pharmaceutical industry for her passion and respect for FDA and international laws and regulations.