Support New Product Introduction (NPI) transfer activities from development into production, including verification of product performance, test requirements, test methods, and readiness of test stations and processes to ensure a smooth transition to manufacturing.
Together with the wider test team regularly re-evaluate testing tools against best practices, cloud-based test infrastructure, observability, and AI-enabled engineering practices to improve productivity, defect prevention, and feedback loops across the delivery lifecycle.
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.