Documentation Management Pillar Lead - QMS

Our client, a leading pharmaceutical company, is seeking a Documentation Management Pillar Lead to spearhead a cross-functional transformation of their Quality Management System. This role involves leading a critical workstream to shape the future-state documentation framework while ensuring alignment with international regulatory standards.

• Lead the scope, objectives, and deliverables for the documentation management pillar within a large-scale transformation project.
• Define the future-state document hierarchy, categories, and governance across the quality management system.
• Design the end-to-end document lifecycle, ensuring controls for compliance, auditability, and inspection readiness.
• Coordinate with cross-functional teams to align process design with digital implementation and validation activities.
• Establish metadata and taxonomy standards to enable effective searchability, traceability, and reporting.
• Translate business and compliance requirements into functional designs for electronic document management systems.
• Support implementation readiness by developing templates, guidance, and training materials in partnership with change management.

• You have a Master’s degree in Sciences, Pharmacy, or a related field.
• You bring 3+ years of experience in documentation management, quality systems, or related quality roles in the pharmaceutical industry.
• You possess strong knowledge of GxP, ICH Q10, and ISO standards related to data integrity and inspection readiness.
• You have hands-on experience with EDMS platforms, specifically Veeva Vault, and the ability to translate business needs into system requirements.
• You bring demonstrated experience in project management, including RAID management, and proficiency in Microsoft 365 and SharePoint.
• You have excellent communication and facilitation skills, with the ability to drive alignment in cross-functional workshops.
• You are fluent in English.

Nice to Haves

• Active knowledge of other languages.
• Experience designing translation workflows and version alignment standards.

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