Clinical Quality Assurance - Program Lead (Associate Director)
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.
Major Accountabilities:
* 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.
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).
* 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.
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.
Skills Desired:
* 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
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