Digital Quality Lead – R&D & Pharmacovigilance Systems

Our client, a leading pharmaceutical organization, is seeking a Digital Quality Lead to provide quality oversight for GxP-relevant digital systems. This role focuses on ensuring the compliant implementation and control of computerized systems used in clinical and pharmacovigilance activities with a specific emphasis on data integrity and validation.

• Ensure compliance of R&D business systems with regulatory frameworks including GCP, GLP, and GVP.
• Develop and maintain the compliance framework for GxP systems through policies, SOPs, and guidance.
• Provide quality assurance oversight during system selection, onboarding, and Computerized System Validation (CSV).
• Perform end-to-end data integrity assessments across complex data flows between internal and external partner systems.
• Manage deviations, investigations, and CAPA activities to ensure alignment with regulatory expectations.
• Collaborate with cross-functional stakeholders to embed ALCOA+ principles across the data lifecycle.

• 3+ years of experience in Computerized System Validation (CSV) within pharmaceutical R&D environments.
• 3+ years of hands-on experience in GCP or GPvP system validation and compliance.
• Knowledge of GxP frameworks including GLP, GVP, and ICH E6(R3).
• Expertise in data integrity principles including ALCOA+, metadata management, and audit trails.
• Experience managing deviations, investigations, and CAPA activities in a regulated domain.
• Ability to assess external vendor systems for compliance and interpret validation packages.
• You possess strong critical thinking, problem-solving, and stakeholder management skills.
• You are fluent in English.

Nice to Haves

• Experience across both PV and clinical systems.
• Experience assessing complex data flows and interfaces between internal and external environments.
• Master’s degree in IT, Engineering, or Life Sciences.
• Broader business acumen beyond technical CSV expertise.

• Start date: ASAP
• Duration: 12 months
• Work regime: Full-time
• Location: Brussels
• Working model: Hybrid with flexible on-site requirements
• Contract: open to both permanent employees and freelancers