Clinical Quality Assurance – Program Lead

Overview

Summary ~ Bieten Sie Qualitätssicherung und Compliance-Aufsicht für Entwicklungs- und Forschungsfunktionen. Fördern Sie die Überwachung von Qualitätsmanagementsystemen und -initiativen innerhalb der globalen, regionalen und Länderorganisation und stellen Sie die Einhaltung der geltenden regulatorischen Anforderungen der Gesundheitsbehörden (z. B. GCP, GLP, GMP, PV, IP) und der Novartis-Verfahren und Qualitätsstandards sicher. Vorbild für gutes Qualitätsverhalten bei gleichzeitiger Förderung einer Qualitätskultur (z. B. richtiges erstes Mal usw.), um die nicht-qualitativ hochwertigen Stakeholder (z. B. NIBR, GDD) positiv zu beeinflussen. Entwickeln, vorantreiben und / oder unterstützen Sie Qualitätsplaninitiativen, um Die Organisationsstrategie, Mission und Vision zu erreichen.

About The Role

Key Responsibilities :

• Proactively provide QA leadership to the business strategy for assigned programs / trials by ensuring considerable organization awareness (e.g. Interrelationship of departments and business priorities).
• Drive implementation of quality strategy within Global Clinical Team (GCT) / Clinical Trial Team (CTT) under responsibility
• Regularly monitor the implementation of the annual Quality Plan pertaining to the assigned programs / studies
• Ensure adequate oversight of proactive quality risk management process in the overseen areas including quality risk assessments and submission / inspection readiness activities and ensure that Clinical Trial Process (CTP) are in control
• Provide robust and clear quality oversight in the following areas of clinical development :
• Support / collaborate with key stakeholders (e.g., Country Development Quality (CDQ), Development Units (DUs), GCT and / or CTT members) to ensure that risks are detected and remediated.
• Support core governance for quality incident management for critical and major deviations pertinent to the programs being assigned and ensure timely escalation when required.
• Provide Good Clinical Practice (GCP) guidance to day-to-day questions arising from Clinical trials deliverables.
• Collaborate with Country Development QA and External Service Providers (ESP) QA to drive initiatives relevant to internal monitoring and outsourced activities Quality oversight.
• Support inspections preparation and facilitation in collaboration with other QA groups within Research & Development Quality (RDQ).
• Support audits and inspections follow-up activities including Corrective & preventative Actions (CAPA) preparation.
• Actively leverage audit / inspection outcomes / trends to sustain improvement in clinical trials conduct.
• Active participation in continuous improvement initiatives (including Work streams) and ensure that areas identified as weaknesses are properly being addressed and executed for sustainability
• Be QA point of contact for the defined trials and attend the meetings and ensure quality is embedded in the decision taking processes.

Essential Requirements

Why Novartis

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