Clinical Quality Assurance - Program Lead (Associate Director)

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

Join our Novartis Network: 

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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