The role is responsible for designing the future‑state QMS documentation architecture, including document hierarchy, metadata model, lifecycle processes (including translation), and governance, ensuring alignment with GxP regulations, industry standards, and internal quality strategy. The Documentation Management Expert (QMS Transformation) plays a key role in a cross‑functional program aimed at the end‑to‑end transformation of the Quality Management System (QMS). * Define the future-state document hierarchy for all QMS procedural documents, including Governance & Procedures, Quality Manual, Policies, SOPs and SOP-Ais, Standards and User Guides-A * Ensure alignment between the document hierarchy and ICH Q10, GxP, ISO standards, and internal quality governance principles. * Collaborate with Quality Systems and IT to ensure metadata design is system-ready.
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