Senior GCP Advisor in R&D Quality

Found in: beBee S DK - 4 weeks ago

Søborg, Denmark Novo Nordisk AS - VTx Full time

Looking for a dynamic and challenging role within clinical process management? Do you dream of using your GCP knowledge, process optimisation skills and quality mind-set in a highly professional and engaged global environment? Do you have a “can-do” attitude, and do you want to support high quality in the development of innovative treatments for patients? If yes, 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.

In Clinical Quality, we support the clinical development organisation globally and drive a great deal of activities such as:

ensuring processes and standard operating procedures (SOP’s) are in compliance with external and internal requirements, being Clinical Quality partners to key projects and line of business, providing GCP support, leading the GCP inspections, reviewing and approving audit CAPA plans performing vendor assessments, trying to impact external clinical requirements and sharing Clinical Quality and GCP knowledge. taking part in due diligence activities when looking at acquiring new assets, taking part in cross organisational improvement projects and providing general quality & compliance support .

We are busy, and we are on an exciting journey, bringing quality to the top of the agenda throughout the R&D organisation. Would you like to be part of this journey?

The Position


The open position is in our Clinical QMS department. As a Senior GCP Advisor, your primary responsibility is to manage updates to our standard operating procedures (SOP’s), Content Control/Process Management processes for clinical trials and ensure compliance to GCP regulations on behalf of the Process Quality Assurance (PQA). You will be serving as a GCP Advisor, where you will advise line of business regarding quality and ensuring a quality mind-set. Moreover, your role involves providing support during GCP inspections. 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 the right interpretation of GCP regulations as the PQA delegate. Collaborating with the Novo Nordisk Process Manager in a process group, following process management guidelines. Ensuring maintenance of global clinical SOPs and ensuring compliance with external & internal requirements. Attending SOP council meetings and raise/present/discuss relevant quality concerns. Capability to work independently, leveraging robust GCP knowledge and being updated with changing regulations and QMS needs. Ensuring global consistency and compliance in clinical development process through process documentation, information sharing, and guidance. Being the quality anchor for worldwide clinical development processes. Providing support to stakeholders inside and outside R&D Quality during GCP inspections as applicable

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 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 required.


You have a positive and pragmatic approach to problem solving, and you are eager to create, optimise and simplify processes around you. You are proactive, courageous 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 but can work independently, and you thrive working across departments in an international organisation.
 

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 can offer you to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.

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