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

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

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? Our Novartis Network

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Mid-Senior level

Employment type

Full-time

Job function

Health Care Provider

Industries

Pharmaceutical Manufacturing

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