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 computerised 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 computerised 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