Digital Quality Lead

As a member of the Quality organization, the R&D and PV Digital Quality Lead ensures robust quality oversight of GxPrelevant 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 fitforpurpose, 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 decisionmaking. MAJOR RESPONSIBILITIES 1. GxP System & Technology Compliance Ensure GLP, GCP, GVP and GRA business systems are fully compliant with regulatory expectation...