Amy Stevens

About Amy Stevens

As the Associate Director of QA Systems at CARsgen Therapeutics, I oversee the regulatory compliance and product quality of the site\'s GMP operations and provide strategic guidance to the executive management. With over 25 years of experience in quality assurance roles in the biotechnology industry, I have acquired extensive knowledge and skills in vaccines, gene therapy, and cell therapy.I am passionate about ensuring the quality and safety of innovative products that can improve the lives of patients. I have successfully managed batch disposition, tech transfers, CQV, and EM review for clinical and commercial products, as well as facilitated the change control, CAPA, and training processes. I have also participated in or conducted audits of external vendors and interfaced with cross-functional groups and CMOs to support supply chain management. I am always eager to learn from regulatory guidance, professional publications, and personal networks, and to contribute to the development of the Quality Management System.

Experience

1. Associate Director Qa

   Pelthos Therapeutics

   Jul 2024 — Present · Durham, NC, US

   Implementation and maintenance of all aspects of the Quality Management Systems- Ensure ongoing regulatory inspection readiness- Manage the eQMS MasterControl, Document Control, employee training, and raw material disposition- Assist to create and implement site Quality metrics

Education

• Bridgewater State University

  Bachelor of Science (B.S.)

  1990 — 1992