Global Paper archivist Governance Lead & Process Data Owner
Contracting – Brabant Wallon
Your responsibilities:
The company is creating a new global role to take full ownership of paper archiving governance across all sites and affiliates.
Although a global paper archiving process already exists, its local implementation has not been consistently followed or monitored, leading to gaps, risks, and deviations.
The objective is to harmonize, structure, and operationalize paper archiving practices globally, ensure inspection readiness, and reduce regulatory, data privacy, and operational risks.
The role will also act as Process Data Owner, the paper archiving system already live in several countries and being extended further.
- Interacting with global and local stakeholders to understand how paper archiving is implemented at site level.
- Assessing gaps based on existing assessments and defining practical action plans.
- Building and animating a community/network of archivists.
- Supporting and governing the Doxis system (validation status, access, data structure, user support).
- Reviewing and aligning retention schedules, procedures, and documentation.
- Managing topics related to external archiving vendors (governance, access, quality agreements).
- Preparing for inspections, managing deviations and CAPAs, and driving continuous improvement initiatives.
- The role requires autonomy, initiative, and a “helicopter view” of global archiving activities.
Your profile:
- Minimum 5 years of experience in records management or archiving within a regulated environment, with enough experience to work independently and proactively without close daily supervision.
- Solid experience in paper archiving / records management.
- Experience in a regulated environment (preferably pharmaceutical or healthcare).
- Strong understanding of data integrity principles (ALCOA+).
- Strong communication skills and ability to work within a global network.
- Comfortable working in English and French.
- Strong organizational and stakeholder management skills.
- Soft skills (initiative, autonomy, communication, project mindset) will be a key evaluation criterion.
Nice to have:
- Knowledge of GxP environments and differences between manufacturing, non-clinical, etc.
- Experience with document management or archiving systems.
- Project management skills.
- Experience with external archive vendors.