Analytical systems & data integrity specialist

Analytical Systems & Data Integrity Specialist

Location: Braine-l'Alleud (hybrid working model)

Engagement: Freelance ASAP until December 2027 (possible extension)

Overview

We have partnered with a large global pharmaceutical organisation to appoint a Data Integrity Specialist within Analytical Development. This role has been created to strengthen and harmonise Data Integrity practices following new corporate requirements and the integration of different teams across New Chemical Entities (NCE) and Biologics. The focus is on improving, aligning and standardising existing processes across a complex environment covering both GMP and non-GMP activities. You will join a Compliance & Data Integrity team of 12, working in a highly transversal setup supporting approximately 250 scientists and analysts. The position offers a blend of hands-on operational work, cross-functional collaboration, and continuous improvement initiatives within a project-driven environment.

Requirements

• 3–5+ years’ experience in a relevant Data Integrity or analytical laboratory environment
• Background within a pharmaceutical or life sciences setting (GxP essential)
• Proven experience working in analytical development or lab-based environments
• Ability to operate effectively in a matrix environment and influence cross-functional stakeholders
• Strong organisational and project-oriented mindset with structured reporting capabilities
• Comfortable balancing operational responsibilities with strategic improvement initiatives

Hard Skills

• Strong hands-on expertise with Waters Empower (critical)
• Experience with SoftMax Pro or other analytical systems is highly desirable
• Deep understanding of Data Integrity principles including ALCOA+ and 21 CFR Part 11
• Practical experience with analytical laboratory systems (not purely theoretical)
• Experience conducting audit trail reviews, data checks, and user access management
• Exposure to deviation investigations, root cause analysis, and CAPA processes
• Familiarity with system governance and administration, including defining rules and best practices
• Knowledge of inspection readiness and audit preparation

Soft Skills

• Strong stakeholder management skills with the ability to challenge and influence
• Clear and structured communication style
• Analytical and detail-oriented mindset
• Ability to work collaboratively across QA, IT, and laboratory teams
• Proactive approach to identifying improvements and driving harmonisation initiatives
• Comfortable facilitating workshops and working in a project-based setting

Qualifications

• Degree in a scientific discipline (e.g. Chemistry, Biochemistry, Pharmaceutical Sciences or equivalent)
• Experience in a regulated pharmaceutical/GxP environment
• Familiarity with Data Integrity frameworks and regulatory expectations
• English fluency required; basic French is advantageous