Knowledge Management Expert

Job description

This role 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 mission consists of systematically mapping global and regional GxP regulations, guidelines, and standards to internal Quality policies, processes, and procedures.

The consultant will :

• Identify gaps, overlaps, and misalignments between regulations and internal documentation, and collaborate with QMS Process Owners to drive remediation.
• Involve building, maintaining, and continuously updating a centralized repository of all applicable regulations and guidelines, including EMA, FDA, ICH, PIC/S, and other relevant authorities.
• Maintain oversight of how regulatory requirements are embedded across the GxP QMS and will 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.
• Create 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 to promote a culture of knowledge stewardship and continuous learning.

Criteria

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Engineering, or a related field.
• Strong experience in GxP Quality Assurance, Quality Systems, Regulatory Affairs, or a related domain.
• Solid understanding of global pharmaceutical regulations, including EMA, FDA, and ICH guidelines.
• Experience working with QMS frameworks and documentation systems.
• Ability to interpret complex regulations and translate them into clear, actionable requirements.
• Strong skills in structuring and organizing information in a logical and transparent way.
• Ability to collaborate effectively with cross?functional partners.
• High attention to detail, ensuring accuracy and completeness in all regulatory mapping and documentation.
• Strong analytical thinking abilities.

Offer

• Attractive salary/rate in line with the market and your experience
• Salary package with very competitive extra-legal benefits
• Optimum work-life balance thanks to 12 ADV days, sliding hours and homeworking possibilities
• Join a community of over 160 consultants in quality and regulatory affairs, with many social events organized throughout the year
• Training and workshops to develop/share your skills