In accordance with regulatory requirements related to MAH (Marketing Authorization Holder), BLA (Biologics License Application), and other applicable regulations, coordinates, compiles, reviews, and ensures the completeness, accuracy, and timely submission of all project-related quality and regulatory documentation packages.
Supports QM Manager in overseeing the internal Corrective and Preventive Action (CAPA) process for both factory and office functions, ensuring timely investigation, implementation, and closure of corrective actions. Performs data trending monthly for reporting at CRB meeting and inputs to Management Review.
Design output and reporting so a non-technical reviewer (a PM) can quickly validate what the AI did and why, and confidently sign off — or reject and flag what's wrong.