Provide QA leadership and guidance for the design and implementation of eBR and paperless manufacturing processes.
Define and approve review by exception (RBE) strategies, including deviation thresholds, exception handling, and QA review models.
Ensure digital manufacturing solutions are aligned with GMP, data integrity principles (ALCOA+), and applicable regulatory requirements (e.g., FDA, EU).
Partner with Manufacturing, Automation, IT, and Quality teams to embed quality-by-design into digital workflows.