Clinical Development QA Lead

Novartis; Schweiz; Vor Ort; EUR 148.000 - 201.000; Vollzeit

Zusammenfassung

Novartis is seeking a Development Quality Assurance Manager to assure quality oversight for activities across country operations, ensuring GCP and GPvP compliance and patient safety. The role collaborates with local Development colleagues, Medical Affairs, and NCQ to implement the Quality Management System and ensure audit readiness and continuous improvement.

The position oversees local QA activities, quality plans, training, and CAPA management, coordinating inspections and risk mitigation

Qualifikationen

• Lead QA activities to assure GCP/GPvP compliance across country operations.
• Oversee local Quality System implementation and training readiness.
• Coordinate CAPA processes and inspections with global and local stakeholders.

Aufgaben

• Local Quality System oversight to ensure GCP and PV processes comply with global requirements.
• Develop and monitor the Quality Plan (QP) deliverables for GCP and PV areas.
• Ensure training systems exist for GCP, PV, and related Development activities; maintain inspection-ready documentation.
• Drive Clinical/PV QA investigations and implement robust CAPA plans.
• Identify and manage quality risks with root-cause analysis and mitigation actions.
• Provide leadership for GCP and GPvP HA inspections and post-inspection actions.
• Lead audit activities and follow-up with auditees to implement corrective actions.
• Approve and manage local CAPAs ensuring timely closure by responsible owners.
• Oversee ESP/Supplier QA activities in the local context.

Jobbeschreibung

Novartis is seeking a Development Quality Assurance Manager to assure quality oversight for activities across country operations, ensuring GCP and GPvP compliance and patient safety. The role collaborates with local Development colleagues, Medical Affairs, and NCQ to implement the Quality Management System and ensure audit readiness and continuous improvement.

The position oversees local QA activities, quality plans, training, and CAPA management, coordinating inspections and risk mitigation