GCP Advisor Specialist

3 weeks ago

Søborg, Denmark Novo Nordisk AS Full time

We are expanding in our team working with integrations and are looking for a new GCP advisor specialist in the Clinical Compliance department, in R&D Quality

Do you dream of using your GCP knowledge, clinical research experience and perhaps GCP audit experience and last but not least your quality mind-set in a highly professional and engaged global environment? Have you worked with clinical quality, and will you bring a ‘can-do’ attitude to support high quality in the development of innovative treatments for patients? 

Then you could become our new GCP Advisor Specialist. 

The position
As a GCP Advisor Specialist in our Integrations team, you will have the opportunity to:

Support and ensure a smooth and well-integrated process of acquired assets into our organization. Shape and optimize the framework for the clinical quality role in integrations. Take ownership and responsibility for contributing to the right quality level in the global organization.

You may also be involved in improvement/optimization projects, act as a quality partner for key projects/lines of business, and provide GCP advice to stakeholders.

Qualifications
To be successful in this role, we are looking for someone with the following qualifications:

A degree in pharmacy, medicine, science, or a similar field At least 5 years of experience in clinical research and drug development Solid knowledge of GCP and other relevant regulations Experience in due diligence and integrations is preferred Experience in clinical quality assurance, trial management/monitoring, or GCP audits is required Strong communication and interpersonal skills Proactive, courageous, and detail-oriented Fluent in written and spoken English.

You take a positive and pragmatic approach to problem solving and you are eager to create, optimise and simplify processes around you. You are a team player, but can work independently and you thrive working across departments in an international organisation.

About the department
Clinical Compliance is one of four sister departments in Clinical Quality which is part of R&D Quality in Novo Nordisk. 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 Clinical Quality, we support the development organisation and drive many activities such as:

Being Clinical Quality partners to key projects and line of business  Taking part in integration activities when acquiring new assets Providing GCP support globally  Leading the GCP inspections Reviewing and approving audit CAPA plans Performing vendor assessments and trying to impact external clinical requirements and sharing clinical Quality and GCP knowledge to the global organisation as well as supporting and maintaining the Clinical QMS.

We also take active part in cross organisational improvement projects and 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?

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