As a member of the Quality organization, the R&D and PV Digital Quality Lead ensures robust quality oversight of GxP‑relevant digital systems, with a particular focus on systems used in clinical activities. The role focuses on the compliant implementation and ongoing control of computerized systems and associated data processes, with particular attention to Computerized System Validation (CSV) and Data Integrity (DI) requirements. Working in close collaboration with various QA teams, Clinical Operations, and other stakeholders, the Digital Quality Lead contributes to ensuring that all computerized systems are fit‑for‑purpose, validated, and operated in accordance with global regulatory expectations, and that data generated or processed by these systems meet the integrity and reliability standards required for regulatory decision‑making.
MAJOR RESPONSIBILITIES
1. GxP System & Technology Compliance
• Ensure GLP, GCP, GVP and GRA business systems are fully compliant with regulatory expectations (e.g. OECD, ICH, GVP) and UCB digital governance requirements.
• Maintain and evolve the compliance framework for GxP-relevant systems (policies, SOPs, guidance).
• Provide QA insight during system selection, onboarding, validation, and ongoing oversight.
• Support investigations, deviations, CAPAs, and inspection-readiness activities related to DI or system failures, ensuring completeness and alignment with regulatory expectations.
2. End-to-End Data Integrity (DI) Governance & Compliance
• Ensure end-to-end Data Integrity across all GxP-relevant data flows, from initial data capture in external partner systems through all transformations, transfers, and integrations into UCB-owned environments.
• Work with Computer System QA team and Clinical Operations to ensure that DI controls (including ALCOA+ principles, metadata management, audit trails, system-to-system data transfer checks, and dataflow mapping) are embedded across the full data lifecycle.
• Assess and document Data Integrity risks associated with externally operated systems and the interfaces linking them to UCB systems, ensuring that controls are in place to protect data reliability, and traceability.
• Contribute to the development, implementation, and continuous improvement of DI practices aligned with ICH E6(R3) expectations and EMA guidance on sponsor oversight of computerized systems.
Requirements
• Bachelor’s Degree required, master’s degree preferred (IT, Engineering, Life Sciences, or related field).
• Prior experience in Pharmaceutical R&D with exposure to GxP computerized systems.
• Knowledge of GLP, GCP, GVP and GRA regulatory frameworks and associated expectations for computerized systems (e.g., OECD GLP, ICH E6(R3), EU GVP Module I/IX).
• Strong understanding of Computerized System Validation (CSV) principles, including risk-based approaches and system lifecycle activities.
• Hands-on experience in GPvP or GCP system validation.
• Experience with data integrity requirements (ALCOA+, metadata, audit trails, dataflow controls) and regulatory expectations for end-to-end data governance.
• Experience in managing deviations, investigations, and CAPA activities within at least one GxP domain.
• Ability to assess external vendor systems for compliance, validation status, and DI risk, including interpretation of validation packages and supplier documentation.
• Ability to interpret complex data flows across external and internal systems and identify data integrity risks across the full lifecycle.
• Strong critical-thinking and problem-solving skills with the ability to apply regulatory expectations to practical system scenarios.
• Ability to work effectively with cross-functional teams to align expectations and ensure consistent compliance across shared system