Senior GCP Advisor Specialist (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 in depth 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. 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 GCP Advisor Specialist in our Clinical QMS department , your primary responsibility is to manage updates to our standard operating procedures (SOP’s) covering the Establish Clinical Evidence process by ensuring compliance with GCP and regulatory requirements. Furthermore, you will be handling new external requirements and taking lead on impact assessments in cooperation with the NN process manager and topic lead.

You will be serving as a quality and process advisor, where you will support colleagues and projects regarding quality and ensuring a quality mind-set. Your continuous focus on quality improvement will be an essential aspect of your job.

Your main responsibilities will include:

• Verifying and approving Standard Operating Procedures (SOPs) and ensuring compliance with external & internal requirements.
• Handling and processing external clinical requirements impacting the clinical area.
• 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.

You will be part of a dynamic and hybrid team with colleagues working from Denmark and India. This position is based in Søborg, Denmark. 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

You have a degree in nursing, pharmacy, medicine, science or similar and a strong command of written and spoken English. You have at least 8 years of experience in clinical research and drug development, as well as a strong knowledge of GCP and other relevant regulations. Experience within clinical quality assurance, trial management/monitoring, or GCP Audits is an advantage.

To excel in this role, we are looking for someone with the following qualifications:

• Work independently, leveraging strong GCP knowledge and being updated with changing regulations.
• Experience in managing compliance within clinical development.
• Solid experience in verifying and approving SOPs and interpreting GCP.
• Ability to collaborate effectively with cross-functional teams and stakeholders.
• Excellent communication and presentation skills.
• Proactive mindset with a focus on continuous quality improvement.
• Pragmatic approach to problem solving and strong ambition to create, optimize and simplify processes.

Working at Novo Nordisk

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world.

Contact
For further information, please contact Kate Bruun Lunding at +45 3077 5507 or get to know us better by visiting www.novonordisk.com/careers

Deadline
5 May 2024

We will be screening and interviewing on an ongoing basis.

We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us! Together, we go further.

Together, we're life changing .