Senior GCP Advisor in R&D Quality (Denmark, Søborg)

Jobbeskrivelse
Placering
Søborg, Denmark

Jobkategori
Quality

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Looking for a dynamic and challenging role within clinical process management? Do you thrive when using your solid GCP knowledge, process optimisation skills and quality mind-set in a highly professional and engaged global environment? If so, then we have the perfect opportunity for you!

Apply now and join a great team where focus is on collaboration, individual development and complex problem solving.

About the department
The Clinical Quality Management System (QMS) department is one of four sister departments in Clinical Quality, which is part of R&D Quality at Novo Nordisk. We play a vital role in supporting the drug development process to ensure high quality as well as fit-for-purpose processes and procedures. At 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.

The position
As a Senior GCP Advisor in our Clinical QMS department, your primary responsibility will be handling new external requirements and taking lead on impact assessments in cooperation with the NN process manager and topic lead. Furthermore, you will be serving as a quality and process advisor, where you will support colleagues and projects regarding quality and ensuring a quality mindset. Your continuous focus on quality improvement will be an essential aspect of your job.

Your main responsibilities will include:

• Handling and processing external clinical requirements impacting the clinical area
• Ensuring quality and timeliness of the interpretation of the new requirements
• Ensuring global consistency and compliance in clinical development processes through process documentation, information sharing, and guidance
• Being the quality partner for improvement projects.
• Providing support to stakeholders inside and outside R&D Quality during GCP inspections as applicable.
• Attending stakeholder meetings and raise/present/discuss relevant quality concerns
• Verifying and approving Standard Operating Procedures (SOPs) and ensuring compliance with external & internal requirements

You will be part of a dynamic and hybrid team with colleagues working from Denmark and India. Preferably this position is placed at our HQ in Søborg, Denmark, but virtual option might be available for the right candidate. The position offers high impact, flexibility, and you are expected to take ownership and responsibility for setting the right quality level in the global organisation.

Qualifications
We expect you to have:

• A degree in nursing, pharmacy, medicine, science or similar.
• A strong command of written and spoken English.
• At least 5 years of experience in clinical research and drug development, as well as a solid knowledge of GCP and other relevant regulations.
• Experience within clinical quality assurance, trial management/monitoring, or GCP Audits is an advantage, and experience in verifying and approving SOPs and interpreting GCP, is preferred.
• HQ and/or affiliate experience is an advantage.
• Knowledge in managing compliance within clinical development

In addition, we are looking for someone who can work independently, leveraging solid GCP knowledge and being updated with changing regulations. You have the ability to collaborate effectively with cross-functional teams and stakeholders, and excellent communication and presentation skills is a must. You should come with a proactive mindset with a focus on continuous quality improvement, and you have a pragmatic approach to problem solving and strong ambition to create, optimize and simplify processes.

Working at Novo Nordisk
At Novo Nordisk, we do not wait for change. We drive it. We are a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing and sales – we are all working to move the needle on patient care.

Contact
For further information, please contact Kate Bruun Lunding on +45 30775507 or get to know us better by visiting www.novonordisk.com/careers

Deadline
5 January, 2025.

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

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

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.