Author, revise, review, and approve Quality Management System documents, including SOPs, CAPAs, Deviations, Change Controls, test methods, protocols, validation documentation, certificates of analysis, and equipment qualification documentation. This role is focused on identifying and mitigating compliance risks before and during production execution, driving adherence to cGMPs and internal procedures, and ensuring that when deviations occur, corrective actions are appropriate, timely, and thoroughly documented.