Description
The Systems Validation Lead assists and guides in project development and implementation of IT applications and initiatives supporting the Foundation’s Information Technology (IT) and Quality Assurance (QA) departments. This role acts as a liaison between Foundation IT and QA, and Foundation divisions like the Skirball Center for Innovation (SCI) and the Clinical Trials Center (CTC) for project support and new initiatives. The position focuses on medical imaging software, image transfer platforms, and clinical data systems in a highly regulated preclinical and clinical trial environment. It involves overseeing the entire validation lifecycle for GxP-regulated applications, developing validation strategies, leading execution activities, and ensuring systems are fit for purpose and controlled. The role also serves as a Subject Matter Expert on Computer System Validation (CSV), providing guidance on regulatory compliance and assisting in drafting procedures and policies.
