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GCP Advisor Specialist

GCP Advisor Specialists for R&D Quality
We are expanding and are looking for 3 new GCP specialists in R&D Quality.


Do you dream of using your solid GCP knowledge, process optimisation skills and quality mind-set in a highly professional and engaged global environment? Can you bring a ‘can-do’ mindset to support high quality in the development of innovative treatments for patients? Then you could be one of our new GCP Advisor Specialists. 

About the department
R&D Quality is part of the Development organisation and we play a vital role in supporting the drug development process to ensure high quality as well as fit-for-purpose processes. In Novo Nordisk, we have an ambitious drug development program and we work in a global setting with focus on delivering viable products that make a difference to patients and ultimately benefit society. 

In R&D Quality, we are responsible for our Quality Management System, we provide GCP support globally, we lead the GCP inspections, we perform vendor assessments and provide GCP quality & compliance support, including IT and device quality support, to the global organisation. We take active parts in cross organisational improvement projects in addition to provide general quality & compliance support to our global organisation.

We are busy and are on an exciting journey bringing quality on top of the agenda throughout the R&D organisation – and maybe you are the one to join us on this journey?

The positions

In close collaboration with your colleagues in R&D Quality, you will ensure that Novo Nordisk is in compliance with GCP and other relevant external and internal requirements in an optimal way without putting unnecessary burden on the organisation. The different positions cover a range of quality and compliance tasks including:
• being responsible for developing and maintaining our quality management system, with a strong focus on GCP and compliance globally. 
• providing GCP support to stakeholders globally, 
• being a Quality Partner for our stakeholders
• be the quality support and partner for a Phase 1 unit in Denmark

You will be part of a dynamic area, where the positions offer high impact, and where you are expected to take great ownership and responsibility to setting the right quality bar in the global organisation. 

Qualifications
You have a degree in pharmacy, medicine, science or similar and a strong command of written and spoken English. You have at least 10 years of experience in clinical research and drug development, as well as solid knowledge of GCP and other relevant regulations. Experience within clinical quality assurance, project management, trial management/monitoring, Phase 1 trials or GCP Audit is required.

You take a positive and pragmatic approach to problem solving and you are eager to optimise and simplify processes around you. You are proactive, courageous and have strong communication and interpersonal skills. You are organised, detail-oriented without losing the big picture and quality-conscious as well as curious by nature. You are a team player and you thrive working across departments in an international organisation.


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