Clinical Quality Assurance - Program Lead; Associate Director

Job Description Summary

Employment Type:

Full‑time | Regular, Hybrid, #LI-hybrid

Location:

London (The Westworks) or Dublin (NOCC)

Novartis is unable to offer relocation support for this role: please only apply if the locations of Westworks, London or Dublin are accessible for you.

The Associate Director, Clinical Quality Assurance (QA) will provide quality oversight for the end-to-end clinical process for the clinical trials under responsibility to ensure compliance with the Health Authorities requirements, the internal standards and a full adherence to patients’ safety, rights and well-being.

• 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; lead 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.

• 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).
• Extensive experience of involvement in regulated activities (GCP/ Pharmacovigilance (PV)), clinical development and/or QA positions with strong understanding on clinical trials.
• 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.
• Experience in managing projects.
• Strong skills in GCP, quality and/or clinical development.

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Business Partnering, Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Organizational Saviness, Problem Solving Skills, Regulatory Requirements knowledge, Risk Management, Stakeholder Management.