Senior GCP Advisor for R&D Quality

• Quality
• Søborg

Being part of Novo Nordisk Research & Development means working at one of the world’s largest and most successful biopharmaceutical companies. Our R&D organisation is vital to Novo Nordisk and now we offer a talented person with an interest in clinical quality the opportunity to join us as our new Senior GCP Advisor.

About the department

R&D Quality is a part of Global Development. In Global Development we take responsibility for new products based on proteins and peptides from early development phases to product introduction. We are responsible for managing clinical drug development worldwide, securing that the process lives up to uniform global standards, regulations and business ethics. We work in global project teams with focus on delivering viable products that make a difference to patients and ultimately benefit society.

The area R&D Quality is divided into three departments. The open position is as a Senior GCP Advisor in the Global Clinical Processes & IT department. The department is responsible for clinical and non-clinical deviations, serious breach handling, IT quality support and QA, CAPA for devices, vendor assessments as well as providing GCP advice to the organisation.

The job
The job offers exciting challenges in developing and maintaining our Quality Management System (QMS), with a strong focus on GCP and compliance globally. Together with 7 colleagues, you will be responsible for ensuring that Novo Nordisk maintains one global clinical QMS in compliance with GCP and other relevant external and internal requirements. You will be working in a dynamic department where flexibility on tasks is required. The task mainly includes the role as GCP advisor in the approval process of clinical and non-clinical deviations and support to handling of potential serious breaches. You will also be supporting the team in training our stakeholders in deviation handling.

Qualifications
You have a degree in pharmacy, medicine, science or similar and a strong command of written and spoken English. You have experience in clinical research and drug development, as well as solid knowledge of GCP and other relevant regulations. Experience within clinical quality assurance, trial management, or monitoring is required. Good training skills are preferred.

You take a pragmatic approach to problem solving and have strong interpersonal skills. You are organised, detail-oriented without losing the big picture and quality-conscious. You’re a team player who thrives working across departments in an international organisation.

At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.

Contact

For further information, please contact Hanne Lang at +45 3079 1989 or Susanne Nørskov at +45 3079 8151.

Deadline
10 November 2019.

We are screening and interviewing on an ongoing basis.

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.