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Location

Barcelona | Spain

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Job description

About the Role

Location: Barcelona or Madrid (Hybrid)

You will be joining a team of 40 highly talented CQA professionals who are based in various countries across the globe!

As our Associate Director, Development Unit CQA (Clinical QA) Program Lead, you will provide strategic Quality oversight on the entire Clinical Trial Process (CTP) for the clinical trials under responsibility in order to ensure compliance with the Health Authorities requirements, the internal standards and a full adherence to Patients' safety, rights and well-being. This role reports to the Global Head, Development Unit CQA Programs.

Your responsibilities will include, but are not limited to:

- Proactively provide strong QA leadership to the business strategy for assigned trials by ensuring considerable organization awareness (e.g. Interrelationship of departments and business priorities)
- Support implementation of the quality strategy within GCT under responsibility.
- Regularly monitor the implementation of the annual Quality Plan pertaining to the Clinical chapter and ensure that all delayed activities have a documented rational and appropriate escalation.
- 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 CTP processes are in control
- Provide robust and clear quality oversight in various areas of clinical development.
- Actively leverage audit/inspection outcomes/trends to sustain improvement in clinical trials conduct.
- Support 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.

Diversity & Inclusion / EEO

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Role Requirements

Degree in Life Sciences, Pharmacy or Medicines.

Extensive years of involvement in regulated activities (GCP/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.

Sufficient years of proven experience in managing projects.

Ability to effectively interact with and present to senior management at all levels, as well as to external audiences and inspectors.

Strong skills in GCP, quality and/or clinical development.

What you'll receive:
Competitive Salary, Company Pension Plan, Life and Accidental Insurance, Flexible working hours, Hybrid working model, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.

Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:

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?

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:

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Salary