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. Document Lifecycle & Translation Process Design * Define end-to-end lifecycle processes for QMS procedural documents, including: Creation and drafting, Review and approval, Distribution and effective use, Periodic review and revision, Archival and obsolescence * Ensure lifecycle processes are inspection-ready and auditable. Process Design, Alignment & Continuous Improvement * Translate project outputs into clear, usable process documentation and guidance. * Experience with document control processes and QMS frameworks in the pharmaceutical or biotech industry. * Proven ability to design, optimize, and govern quality processes.
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