Pauwels Consulting Logo

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.
# 99855
With a plus sign and country code (e.g. +32 400 00 00 00).
We accept Word and PDF files up to 3 MB.
Candidates must be legally authorised to work in the EU and possess the required language skills for the job location.
Not sure if this job is right for you? Chat with Alex, our AI career coach, and discover the vacancies that match your profile.