Job Description Summary
LOCATION: London, UK, Dublin, Rep of Ireland, Barcelona, Spain
ROLE TYPE: Hybrid Working, #LI-Hybrid
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.
Job Description
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.
• 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).
• 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? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards:
Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
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
