Documentation Management Expert H/F/X

Description de la fonction

Contracting - Brabant Wallon

Role Purpose 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). 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. This position operates in a project context, focusing on definition, design, and standardization, and provides the foundation for future implementation within electronic document management systems (EDMS). Key Responsibilities QMS Documentation & Hierarchy Design 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 Establish clear document categories, relationships, and dependencies across the QMS. Ensure alignment between the document hierarchy and ICH Q10, GxP, ISO standards, and internal quality governance principles. Metadata Model & Document Taxonomy Design and document a standardized metadata framework for QMS procedural documents, including : Naming conventions, Versioning rules, Classification attributes, Ownership and governance fields Define metadata requirements to support: Searchability and usability, Regulatory traceability, Reporting and KPIs, EDMS configuration and automation Collaborate with Quality Systems and IT to ensure metadata design is system-ready. 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 Design and document translation workflows, including: Trigger points for translation, Language scope and prioritization, Roles involved in translation review and approval, Version alignment between source and translated documents Ensure lifecycle processes are inspection-ready and auditable. Roles, Responsibilities & Governance (RACI) Define and document clear roles and responsibilities for all stakeholders involved in QMS procedures, including: Authors, Reviewers, Approvers, Document owners, Quality governance bodies, Translation contributors Develop RACI models for different document types (Policy, Quality Manual, SOP, SOP-AI, Standard, User Guide). Ensure consistency of responsibilities across functions and geographies. Process Design, Alignment & Continuous Improvement Lead workshops and working sessions to: Assess current-state documentation practices, Identify gaps and inconsistencies, Align stakeholders on future-state standards Translate project outputs into clear, usable process documentation and guidance. Define success criteria and KPIs to measure the effectiveness of the future documentation framework. System Readiness & Implementation Support Provide business and functional requirements to support implementation of the future-state model in EDMS (e.g. Veeva Vault). Support validation, user role definition, and data integrity considerations linked to the new documentation framework. Ensure design decisions support scalability, automation, and long-term sustainability. Change Management & Enablement Develop guidance materials, templates, and standards to support adoption of the new QMS documentation framework. Support communication and training strategies for impacted stakeholders. Act as a subject-matter expert and advisor throughout the transformation program.

Profil

Experience, Skills and Knowledge Strong knowledge of GxP, ICH Q10, ISO 9001, and regulatory requirements related to documentation and data integrity. Experience with document control processes and QMS frameworks in the pharmaceutical or biotech industry. Hands-on experience with EDMS platforms (e.g., Veeva Vault) Solid understanding of document lifecycle management, version control, and procedural governance. Proven ability to design, optimize, and govern quality processes. Used to Microsoft 365 suite. Education & Background Master's degree in Sciences, Pharmacy, or a related field. 3-7 years of experience in documentation management, quality systems, or related quality roles in the pharmaceutical industry. Fluent in French & English

Compétences linguistiques

• Français (atout)

  • Comprendre : Expérimenté - (C1)
  • Écrire : Expérimenté - (C1)
  • Lire : Expérimenté - (C1)
  • Parler : Expérimenté - (C1)