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GCP Lead Auditor in Corporate Quality

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GCP Lead Auditor in Corporate Quality


Gladsaxe, 1 stilling

- Quality
- Denmark - Bagsværd

Have you years of experience within clinical trials worldwide and are you passionate about quality? Are you maybe looking for a career change? Then you may be our new GCP auditor.

Do you want to be part of one of the world’s most successful pharmaceutical companies? Do you burn to contribute to modern and ethical clinical research that makes a difference for millions of people? Do you have a strong quality mindset and do you dream of a job with a high level of responsibility, exposure and interaction with people across many different cultures?

About the department
As a GCP auditor in Novo Nordisk, you will be part of the Quality Research and Developement (R&D) Audits in Corporate Quality.

The department is located in Bagsværd, at the Headquarters in Denmark, and has the global responsibility for performing audits of clinical trials throughout all development phases, as well as system audits worldwide.

Our primary goal is that our audits shall help ensuring the ethical conduct, the safety of the trial subjects, and the data integrity in all clinical research sponsored by Novo Nordisk.

We are dedicated to teamwork, sharing audit best practices within the department and with auditors in other areas, striving to develop a consistent auditing approach at a world-class level.

Currently, the entire Quality R&D Audits department consists of 28 members divided in 3 teams (two in Bagsværd, Denmark and one in Bangalore, India).

The position
As an auditor you will have a high level of responsibility, and you can make a great impact.

Your key responsibility is to perform GCP audits at clinical trial sites and of Clinical Research Organisations (CROs) involved in Novo Nordisk A/S clinical research. Novo Nordisk A/S sponsors clinical trials in 70+ countries, therefore you should expect approximately 80-100 annual travel days outside Denmark.

We require that you are able to work independently. It is expected, that you are analytical and pragmatic.
As an auditor you will interact and communicate effectively with external and internal stakeholders at all organisational levels, and across many different cultures.

You hold a university degree in natural or pharmaceutical sciences. You already have experience as a GCP auditor, or you have documented experience within clinical trials with e.g. trial management, monitoring, data management, biostatistics, or drug safety for at least 7 years.

You have high ethical standards and are committed to the overall aim of ensuring ethical conduct, safety of trial subjects and data integrity. You have good knowledge of GCP and GDP requirements, and you have the ability to understand and interpret the applicable standards in the field of clinical research.

During your professional life you have certainly developed the “eye for detail”, but you put things into perspective and see the “big picture”.

You are an open-minded person, with cultural awareness and excellent communication skills, who likes to be in daily contact with different stakeholders around the world. You thrive in a dynamic and busy environment with changing priorities. Since most of the audits are conducted outside Denmark, you must be fluent in English both orally and in writing.

Please make your application in English.

Working at Novo Nordisk
At Novo Nordisk, decisions and actions are based on their impact on society, the environment and on their potential to generate profit. That makes for a responsible culture with a healthy and engaging working environment.

For further information, please contact Eva Lysdal Maare at +45 3075 1402.

30 May 2016.