GCP Advisor Specialist (Denmark, Søborg)

Jobbeskrivelse
Placering
Søborg, Denmark

Jobkategori
Quality

Ansøg nu

Are you passionate about clinical quality and do you have solid knowledge of GCP, process optimisation skills and a quality mind-set? Will you bring a ‘can-do’ attitude to support high quality in the development of innovative treatments for patients? If yes, then you might be the GCP Advisor specialist we are looking for. Apply now for this exciting job opportunity and join Novo Nordisk – leading global healthcare company!

The position
As a GCP Advisor Specialist, you will be part of a dynamic area where you are expected to take ownership and responsibility for setting the right quality level in the global organisation. You are expected to be a role model; inspire, motivate, and support your colleagues.

Some of your main tasks will include:

• Being Clinical Quality partners to key projects and line of business
• Reviewing and approving audit CAPA plans
• Performing vendor assessments
• Handling Serious Breaches, Clinical Deviations & Change Controls
• Supporting and driving continuous process improvements within and outside the team

Apart from the above core activities, you may also have cross-functional responsibilities within Clinical Quality. Here, we support the trial teams globally in a proactive manner, ensuring that Novo Nordisk is in compliance with GCP and other relevant external and internal require-ments in an optimal way. We participate in improvement projects, we provide GCP advice and training and support the GCP inspection team during inspections.

The open position is based in Søborg, but you will be required to collaborate closely with col-leagues working remotely across various time zones. Therefore, flexibility and adaptability are essential.

Qualifications
To succeed in this role, you need:

• Academic degree in pharmacy, medicine, science or similar
• Several years of experience in GCP and other relevant regulations within clinical re-search and drug development
• Experience within clinical quality assurance, trial management/monitoring, or GCP Au-dits
• Strong command of written and spoken English

On a personal level, you take a positive and pragmatic approach to problem solving and you are eager to create, optimise and simplify processes around you. You are proactive, coura-geous and have strong communication and interpersonal skills. Furthermore, you are organ-ised, detail-oriented without losing the big picture and quality-conscious as well as curious by nature. In addition, you can work independently and as part of a team and you thrive working across departments in an international organisation.

About the Department
Clinical Quality Assurance (QA) is one of four sister departments in Clinical Quality, which is part of R&D (Research and Development)Quality in Novo Nordisk. We play a vital role in sup-porting the drug development process by ensuring high quality as well as fit-for-purpose pro-cesses.

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 ulti-mately benefit society.

Working at Novo Nordisk
Novo Nordisk is its people. We know that life is anything but linear, and balancing what is im-portant at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 50,000 employees. To-gether, we go further. Together, we’re life changing.

Contact
For further information, please contact Najat EL Bariaki, Manager at +45 30791291.

Deadline
18 November, 2024.

You do not need to attach a cover letter to your application, but do remember to include a few sentences about why you are applying in your CV. Please also avoid the use of photos in your CV.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.