General Description

The QMS Business Process Owner is responsible for managing assigned escalated GxP and Quality incidents in an end‑to‑end process on a global level, initiating prevention measures, and maintaining continuous improvement of defined incident management processes within regulated environments.

Processes

• Develop, maintain and implement assigned GxP/Quality incident management processes that align with organizational goals and the latest regulatory requirements on a global level.
• Manage and oversee the intake, triage, investigation, documentation, and resolution of GxP and quality‑related issues and incidents in an end‑to‑end process, including those resulting from deviations, regulatory and/or GxP non‑conformances or other quality events.

Cross‑Functional Collaboration

• Partner with manufacturing, quality assurance, quality control, regulatory affairs, clinical operations, development, patient safety...