GCP Advisor Specialist for R&D Quality

• Quality
• Søborg

Your opportunity

Do you wish to use your solid GCP knowledge, process optimisation skills and quality mind-set in a highly professional and engaged global environment then you may be our new GCP Advisor Specialist?

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 and process optimisation the opportunity to join us.

In Global Development, we take responsibility for new products based on proteins and peptides from early development phases to product introduction to the market. 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 a global setting with focus on delivering viable products that make a difference to patients and ultimately benefit society.

About the department

R&D Quality is part of Global Development and is divided into three departments. The open position is as a GCP Advisor Specialist in the Global Clinical & Research QMS department. The department is responsible for our Clinical QMS including all our CT-SOPs, GCP Advice, Medical Device support and QA function within R&D and participation in cross organisational improvement projects in addition to general quality support to our global organisation.

The position
As a GCP Advisor Specialist you are responsible for developing and maintaining our quality management system, with a strong focus on GCP and compliance globally. In close collaboration with 14 colleagues, you will ensure that Novo Nordisk maintains one global clinical quality management system in compliance with GCP and other relevant external and internal requirements. You will be the GCP expert on the clinical SOPs in the SOP update process, provide GCP support to stakeholders and participate in cross-organisational improvement projects. You will be part of a dynamic department, where the position offers high impact and you will use your expertise to ensure overall compliance with relevant requirement by supporting stakeholders, including affiliate colleagues, in the organisation. You will be involved in stakeholder meetings and cross organisational improvement projects.

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, trial management/Monitoring, or GCP Audit is required.

You take a pragmatic approach to problem solving and you are eager to optimise and simplify processes around you. You are proactive 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.

Working at Novo Nordisk

At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with oppotunities for professional and personal development.

Contact
For further information, please contact Susanne Witzke at +45 3079 2273 (on vacation 11/7-31/7, but please leave a message, and your call will be returned when possible).

Deadline
15 August 2019, however, we will be screening and interviewing on an ongoing basis and may close the job ad before the deadline.

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.