Novartis UK
Clinical Quality Assurance - Program Lead (Associate Director)
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Associate Director, Clinical Quality Assurance (QA) – London (The Westworks) or Dublin
Employment Type: Full-time | Regular, Hybrid Location: London (The Westworks) or [Dublin (NOCC)] (Novartis offers no relocation support—apply only if the location is currently accessible to you)
About the Role
The Associate Director, Clinical Quality Assurance (QA) will provide Quality oversight for the end-to-end clinical process across assigned trials, ensuring compliance with Health Authority requirements, internal standards, and patient safety, rights, and well-being.
Major Accountabilities
Strategic Leadership & Quality Oversight
- Provide proactive quality leadership aligned with business priorities, including understanding interdepartmental dynamics.
- Drive the execution of quality strategies within assigned Global Clinical Teams (GCT) or Clinical Trial Teams (CTT).
- Regularly monitor implementation of the annual Quality Plan for programs/studies.
- Ensure risk-based proactive Quality Assurance (QA), including quality risk assessments and inspection readiness activities.
- Verify that Clinical Trial Processes are in control.
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Collaboration & Governance
- Support and collaborate with key stakeholders (e.g., Country Development Quality (CDQ), Development Units (DUs), GCT/CTT members) to mitigate risks.
- Oversee critical/major deviation management, ensuring timely escalation.
- Provide Good Clinical Practice (GCP) guidance across clinical trial deliverables.
- Partner with Country Development QA and External Service Providers (ESPs) to drive QA initiatives in monitoring/outsourced activities.
Readiness for Audits & Inspections
- Lead and facilitate inspections in collaboration with RDQ (Research & Development Quality allies).
- Support audit follow-up activities, including Corrective & Preventive Action (CAPA) preparation.
- Use inspection/audit trends to foster continuous improvement in clinical trial execution.
Knowledge Sharing & Accountability
- Actively participate in continuous improvement work streams to address gaps sustainably.
- Serve as the primary QA point of contact for assigned trials, ensuring quality embodies decision-making across project meetings.
Essential Requirements
- Bachelor’s degree in life sciences or healthcare required. A PhD, MD, PharmD, or Master’s degree in the same discipline is preferred.
- 8+ years’ experience in regulated activities (GCP, Pharmacovigilance (PV), clinical development, and/or QA), with a strong foundation in clinical trial conduct.
- Competency in global Health Authority expectations (clinical development) and science of product development.
- Experience working independently in matrix/globally distributed environments.
- Demonstrated project management capabilities.
- Strong practical knowledge in GCP, quality frameworks, and clinical development.
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Why Novartis?
Novartis transforms lives through innovative science, driven by volunteers who are collaborative, purpose-driven, and passionate. Join a community creating lasting healthcare breakthroughs. Learn more about our culture and opportunities to grow:
- Novartis Handbook (PDF)
- Full Benefits & Rewards (for career and personal thriving)
Ready to help us shape a brighter healthcare future? Apply if you’re aligned with London/Dublin. ✨
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