Nancy Sajjadi joins The Chain to share her quality control knowledge and experience of adopting a quality-by-design approach for assays. We discuss how the focus of her QC work has changed through the years, and what kind of challenges she foresees as the cell and gene therapy fields move forward. Ms. Sajjadi talks about consulting with clients who are developing cutting edge therapies and explains her approach of creating a “culture of quality” within scientific organizations to lead to more successful outcomes.   Nancy Sajjadi, Independent Quality ConsultantNancy Sajjadi, M.Sc. is an independent quality consultant with over 30 years of experience in biopharmaceutical product development. She began her career as a bench scientist doing malaria vaccine research before turning to development of cell and gene using therapy retroviral vectors for infectious disease, cancer, and cell therapy applications. Her responsibilities there included research, development, and quality control. She left her position as Director of QC at Chiron Technologies Center for Gene Therapy, in 2000 and to start a consulting business.   She has provided services to biopharmaceutical companies, contract laboratories, non-profit organizations, universities, and US government agencies. She has assisted clients in the development, implementation, and improvement of quality programs for a range of biopharmaceutical products in early phase development.  She also has provided technical expertise in assay development, qualification, and validation. Ms. Sajjadi has authored several articles pertaining to bioassays and viral gene therapy, has served on 5 advisory panels for the United States Pharmacopeia (USP) and teaches introductory courses in bioassay design, development, and validation for non-statisticians.