Senior GCP Advisor

Department – R&D Quality Global Business Solution

Are you passionate about clinical quality? Do you have an innovative mindset to drive change in a future-ready environment and support your colleagues and stakeholders by challenging the status-quo in a friendly and open-minded way? If so, there is a unique job opportunity waiting for you as our new Senior GCP (Good Clinical Practice) Advisor. At Novo Nordisk, we will challenge you to do the best work of your life. Apply now and join a growing team, working in an international environment.

The Position

As a Senior GCP Advisor, your primary responsibility is to manage 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 and be a member of the Clinical Trial (CT) SOP Council where you advice line of business  regarding quality concerns, ensuring quality mind-set. Your role also involves in providing support during GCP inspections. Your continuous focus on quality improvement would be an essential aspect of your job. You have been tasked with the following duties:

• Verify and approve Standard Operating procedures (SOPs) and right interpretation of GCP regulations as quality advisor,Collaborate with Novo Nordisk Process Manager in a process group, following Process Management guidelines. Regularly communicate with Process Quality Assurance Delegate (PQAD) to share insights
• Ensure maintenance of global CT SOPs and ensure compliance with internal & external requirements. Attend CT SOP council meetings and raise/present/discuss relevant quality concerns
• Capability to completely work independently leveraging robust GCP knowledge and being relevant with changing regulations and QMS needs
• Provide support to stakeholders in and outside R&D Quality during GCP inspections as applicable
• Ensure global consistency and compliance in clinical development process through process documentation, information sharing, and guidance. Be quality anchor for worldwide clinical development process

Qualifications

• Degree in medical/biological/pharmaceutical science or similar.

• Minimum of 10-12 years of experience within GCP, other relevant requirements affecting the conduct of clinical trials and QMS.
• Pharmaceutical business and knowledge of GCP regulations and guidelines within drug development.
• Extensive experience in conducting clinical trials.
• Experience of overall QMS and quality processes.
• Experience with audits and inspection support.
• Thorough knowledge and understanding of the drug development and life cycle management processes, preferably from participation in project teams.
• Global cross functional experience.
• Team player prepared to work in a dynamic international environment with tight deadlines.
• Ability to influence and set directions.
• Strong personal leadership skills and quality mindset.
• Display strategic -set – with focus on optimising the way processes are handled in NN.
• Project management skills and ability to co-ordinate and facilitate globalised processes.
• Flexibility and team-oriented ready to re-prioritize and adapt to changes in continuously evolving environment.
• Ability to present complex quality issues in a global environment effectively.
• Work independently and lead with clear and confident decision making.
• Sound IT skills and demonstrate excellent presentation and communication skills.

About the department

R&D Quality is part of the Development Organisation and plays a vital role in supporting the drug and device development process to ensure high quality as well as fit-for-purpose processes throughout the entire value chain. We at R&D Quality support LOBs with quality processes/systems and Quality Management Systems activities across Regulatory Affairs and Global Safety, Clinical reporting and Clinical Data Sciences. We provide quality and compliance support to the organization being QAs for deviations, SOPs, change controls, quality monitoring, process reviews, system validations and we are quality partners in transformational projects within Development & Research and Early Development areas. 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

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. 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.

Contact

To submit your application, please upload your CV online (click on Apply and follow the instructions).

Apply Now!

Deadline

29th March 2024.

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.