Documentation Management Expert

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

1. 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.

 

1. 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.

 

1. 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.

 

1. 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.

 

1. 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.

 

1. 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.

 

1. 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.

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