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GCP Advisor Specialist: Drive Excellence in Clinical Quality Process Management
2 weeks ago
Select how often (in days) to receive an alert: Create Alert
GCP Advisor Specialist: Drive Excellence in Clinical Quality Process ManagementCategory: Quality
Location: Søborg, Capital Region of Denmark, DK
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 mindset 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.
The position
As a GCP Advisor Specialist in our Clinical QMS department, your primary responsibility is to manage updates to our standard operating procedures (SOPs) covering the Establish Clinical Evidence process by ensuring compliance with GCP and regulatory requirements.
You will serve as a quality and process advisor, supporting 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:
- Verifying and approving Standard Operating Procedures (SOPs) and ensuring compliance with external & internal requirements
- Supporting digitalisation of key processes and procedures
- 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 raising/presenting/discussing relevant quality concerns
- Handling and processing external clinical requirements impacting the clinical area
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 a 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 8 years of experience in clinical research and drug development, as well as a strong knowledge of GCP and other relevant regulations.
- Experience with digitalization of processes to minimize risks through design and focus on quality that matters is preferred.
- Experience within clinical quality assurance, trial management/monitoring, or GCP Audits is required.
- Solid experience in verifying and approving SOPs and interpreting GCP, and experience in managing compliance within clinical development.
- In-depth knowledge of Veeva Vault Platform or other clinical management systems is an advantage.
In addition, we are looking for someone who can work independently, leveraging strong GCP knowledge and being updated with changing regulations. We expect you to be able to collaborate effectively with cross-functional teams and stakeholders, and therefore, it is important that you possess excellent communication and presentation skills. You have a proactive mindset with a focus on continuous quality improvement, and a pragmatic approach to problem solving and strong ambition to create, optimize and simplify processes.
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.
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
Deadline
31 March, 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.
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.
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