Associate Director, Clinical Qa

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Summary

LOCATION : London, UK or Dublin, Rep of Ireland, Barcelona, Spain

ROLE TYPE : Hybrid Working

The Associate Director, Clinical QA will provide Quality oversight for the end-to-end clinical process for clinical trials, ensuring compliance with Health Authorities requirements, internal standards, and patient safety, rights, and well-being.

About The Role

Key Responsibilities :

• Provide QA leadership for assigned programs / trials, ensuring organizational awareness and alignment with business priorities.
• Implement quality strategies within the Global Clinical Team (GCT) / Clinical Trial Team (CTT).
• Monitor the implementation of the annual Quality Plan for assigned studies.
• Oversee quality risk management processes, including risk assessments and inspection readiness activities, ensuring Clinical Trial Processes (CTP) are in control.
• Support and collaborate with stakeholders to detect and remediate risks.
• Manage quality incident governance, ensuring timely escalation of deviations.
• Provide GCP guidance for clinical trial deliverables.
• Collaborate with internal and external QA providers to oversee monitoring and outsourced activities.
• Assist in inspection preparation and follow-up activities, including CAPA.
• Leverage audit and inspection outcomes to improve clinical trial conduct.
• Participate in continuous improvement initiatives and address areas of weakness.
• Serve as QA point of contact for trials, ensuring quality is integrated into decision-making processes.

Minimum Qualifications :

Why Novartis

Join a community of passionate professionals committed to transforming patient lives through innovation and collaboration. Stay connected through our talent community and explore all the ways we support your growth and success.

Seniority level : Director

Employment type : Full-time

Job function : Quality Assurance, Pharmaceutical Manufacturing

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