Knowledge Management Expert
Contracting – Brabant Wallon
Your responsibilities:
The Knowledge Management Expert plays a key role in ensuring that the Quality Management System (QMS) remains fully aligned with applicable GxP regulations and that critical knowledge is efficiently captured, structured, and shared across the Quality organization.
The role is responsible for mapping regulatory requirements to internal QMS policies and procedures, developing and maintaining a repository of regulations and regulatory intelligence, overseeing compliant implementation within the QMS, and enabling the effective flow of actionable knowledge across Quality.
- Regulatory Mapping & Compliance Alignment
- Systematically map global and regional GxP regulations, guidelines, and standards to internal Quality policies, processes, and procedures.
- Identify gaps, overlaps, and misalignments between regulations and internal documentation; collaborate with QMS Process Owners to drive remediation.
- Ensure traceability between regulatory requirements and QMS documents through structured mapping tools or frameworks.
- Monitor changes in relevant regulations and proactively evaluate their impact on the QMS.
- Regulatory Repository Ownership
- Build, maintain, and continuously update a centralized repository of all applicable regulations and guidelines (e.g., EU, FDA, ICH, PIC/S, EMA, local authorities).
- Establish governance for regulatory document lifecycle, version control, and archiving.
- Provide Quality teams with timely access to the most current regulatory information and insights.
- QMS Oversight & Implementation Monitoring
- Maintain oversight of how regulatory requirements are embedded across the GxP QMS.
- Develop and track KPIs or dashboards that measure the completeness and accuracy of regulatory implementation.
- Support internal audits, inspections, and assessments by providing clear regulatory mapping and QMS insights.
- Partner with Quality Systems, Compliance, and Process Owners to ensure adherence to evolving regulatory expectations.
- Knowledge Sharing & Organizational Learning
- Design and implement strategies, processes, and tools to support the effective flow of Quality knowledge across functions.
- Develop user-friendly summaries, guidance documents, and knowledge assets to promote understanding of regulatory expectations.
- Facilitate communities of practice, learning sessions, and cross-functional knowledge exchanges.
- Promote a culture of knowledge stewardship and continuous learning within Quality, eventually expanding these capabilities to wider functions.
Your profile:
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Engineering, or related field.
- Strong experience in GxP Quality Assurance, Quality Systems, Regulatory Affairs, or related domain.
- Solid understanding of global pharmaceutical regulations (e.g., EMA, FDA, ICH).
- Experience with QMS frameworks and documentation systems.
- Fluency in French & English.
Nice to have
- Background in knowledge management, information architecture, or process excellence.
- Experience with digital knowledge tools (e.g., regulatory intelligence databases, document repositories, QMS platforms).
- Familiarity with change management and effective communication strategies.