Documentation Management Pillar Lead - QMS
Life Sciences
Clinical
Master
Advanced (5+)
- Location
- Braine-l'Alleud, Walloon Brabant
- Work type
- Consultancy
- Work model
- Fulltime, Hybrid
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.
Responsibilities
- 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.
Requirements
- 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.
Offer
- Enjoy a competitive salary package with extra perks that recognize your talent.
- Advance your career with a clear growth path, coaching, and mentoring to support you.
- Thrive in a dynamic and supportive environment where you can truly make an impact.
- Work when and where you perform best, ensuring an optimal work-life balance.
- Choose a flexible transport solution, from a company car to a public transport subscription.
- Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
- Grow your skills with external courses and our in-house Pauwels Academy.
- Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
- Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.
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