Clinical Quality Assurance – Program Lead

Choose LocationChoose Location# Clinical Quality Assurance – Program LeadREQ-10061165Sep 10, 2025Spain### 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:*** Bachelor’s degree in life science or healthcare field required. Advanced degree or equivalent education/degree in life sciences/healthcare preferred (PhD/MD/ PharmD/ Masters).* 7 years of involvement in regulated activities (GCP/ Pharmacovigilance (PV)), clinical development and/or QA positions.* Broad understanding of global expectations of Health Authorities in the area of Clinical Development and profound understanding of the science of product* development.* Ability to work independently and in a global/matrix environment.* 3 or more years’ experience in managing projects.* Strong skills in GCP, quality and/or clinical development**Why Novartis:****Join our Novartis Network:****Benefits and Rewards:**Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:**Why Novartis:****Join our Novartis Network:****Benefits and Rewards:** Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:DevelopmentInnovative MedicinesSpainBarcelona Gran VíaES06 (FCRS = ES006) Novartis Farmacéutica, S.A.Basel (City), SwitzerlandDublin (NOCC), IrelandHome Worker - England/Wales, United KingdomLondon (The Westworks), United KingdomQualityFull timeRegulärNoREQ-10061165### Clinical Quality Assurance – Program Lead
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