Senior GCP Advisor

Department – R&D Quality GBS

Are you passionate about quality and simplification? 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, you will provide guidance and support for GCP compliance. You will assess clinical suppliers, perform cross-functional quality signal trending, and have responsibility for CAPA QA. You have been tasked with the following duties:

• As the subject matter expert on clinical supplier assessments, responsible for evaluating compliance with ICH/GCP and working with Clinical Outsourcing Management to mitigate identified risks.
• Support stakeholders, ensure quality and compliance oversight, and promote knowledge sharing both internally and externally. Your goal is to create a positive impact on process and culture to benefit the organization.
• Perform cross-functional data trend analysis to identify quality risks. Share results with stakeholders globally.
• Review and approve action plans for global GCP audit findings. Share knowledge with Clinical Operation for continuous improvement based on lessons learned from clinical Audit CAPA QA team.
• Provide GCP training, assist in process improvement projects, support GCP audits/inspections with Health Authorities globally, participate in relevant GCP working groups, and offer advice on quality issues.

Qualifications

• Degree in medical/biological/pharmaceutical science or similar.
• 10-12 years’ experience in GCP (Good Clinical Practice) and relevant clinical trial requirements is required.
• Through knowledge of GCP and guidelines/regulatory requirements within drug development and life cycle management processes
• Clinical vendor assessment experience
• Experience of overall QMS and quality processes
• Global cross functional experience is preferred
• Communicate complex information effectively and skilled in applying a risk-based mindset to quality aspects
• Flexible and team-oriented, with a strategic mindset focused on optimizing processes leveraging digital inclination
   

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 GBS and Clinical Data Sciences GBS. 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

At Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions. Our treatments today are benefiting millions of people living with diabetes, obesity, and rare blood and endocrine diseases. From our labs to our factory floors, we are discovering and developing innovative biological medicines and making them accessible to patients throughout the world. Since the company was founded in Denmark more than 100 years ago, we have been translating the unmet medical needs of people living with serious chronic diseases into innovative medicines and delivery. Our focus is on these diseases, which affect hundreds of millions of people and are among the most urgent global health challenges. By combining our innovation and commercial excellence, we draw upon insights from patients and partners to transform bold ideas into life-saving and preventive medicines. Our ambition is to take the lead in each of these areas, driving change with an unfailing belief that it can be done.

Contact

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

Apply Now! 

Deadline

8th December 2023

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.