RBQM Principal Process Management Specialist

Risk Based Quality Management 

Søborg (Copenhagen), Onsite 

Are you a clinical operations expert with a deep knowledge of RBQM and core CRA processes and ways-of-working? Step into a global role at the heart of clinical development, owning RBQM processes that safeguard patients, strengthen trials, and drive continuous improvement across Novo Nordisk. 

Read on and apply today! 

Your new role 

As a RBQM Principal Process Management Specialist, you will act as both an RBQM knowledge expert and Process Manager for core CRA processes, e.g. CRA Monitoring, Trial Site Initiation, Managing and Monitoring a trial site and Closure of a Trial, ensuring day-to-day process management aligned with business priorities and stakeholder needs.  

Your main accountabilities will be: 

• Act as a Subject Matter Expert and Process Responsible for core CRA Processes and ways-of-working  

• Process Manager for the core CRA processes and ways-of-working, e.g. CRA Monitoring, Trial Site Initiation, Managing and Monitoring a trial site and Closure of a Trial, or other assigned RBQM-related processes as determined by business priorities 

• Drive successful implementation, operation, and maturation of these processes  

• Content responsible for corporate process content related to these processes in the QMS  

• Keep process information and metadata current  

• Support Requirement Database mapping of process requirements  

• Develop and maintain corporate-level training material for the processes 

• Chair or actively contribute to relevant Corporate or Functional Process Groups 

• Support the Process Owner in defining strategy and direction for the processes, ensuring simple, stable, compliant, and continuously improved processes 

• Conduct process reviews, monitoring activities, and Process Confirmations 

• For GxP activities, support handling and implementation of compliance signals related to the core CRA processes  

Your new department 

Risk Based Quality Management is a global function within Clinical Development focused on ensuring clinical trial data is reliable, participants rights, safety and well-being are protected and ensuring trial quality and inspection readiness. The team owns and continuously improves enterprise‑level RBQM processes, providing expert oversight of core CRA processes globally and across clinical programs. Working closely with trial teams and senior stakeholders worldwide, the department translates regulatory requirements and risk signals into clear, compliant, and practical solutions that strengthen clinical trial delivery. 

The job is based in Denmark or one of the Novo Nordisk virtual hubs (Oxford England, Gatwick England, Bangalore India, Warsaw Poland, Madrid Spain, Istanbul Turkey, Plainsboro USA or Boston USA) - and the scope of work is global. The role supports the RBQM CRA Processes at an enterprise level and may require international travel.   

Your skills & qualifications 

We are searching for a strategic, proactive, and accountable RBQM Principal Process Management Specialist with strong integrity, ethical judgment, and project management talent, who meet the following criteria:  

• Master’s degree in natural sciences or similar and minimum 10 years of relevant practical experience  

• End-to-end insight into clinical development  

• Work experience from the pharmaceutical industry or CROs 

• Experience with GxP processes, Clinical Trial execution, CRA processes and inspections  

• Active experience with RBQM and quality processes is an advantage  

• Demonstrated strong analytical skills and ability to tutor and coach others  

• Experience with continuous process improvement in a regulated environment  

• Fluent in written and verbal English  

Moreover, as a person you are team‑oriented and thrive in collaborative, cross‑cultural environments, with strong communication, presentation, and negotiation skills. You are flexible and able to adapt to a continuously evolving setting, combining a strong analytical mindset with a constant focus on patient safety and quality that matters. 

Working at Novo Nordisk 

We're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today. The video below features colleagues worldwide speaking about why they’re proud to work at Novo Nordisk and highlights the culture, collaboration and long-term impact. Together, for the long-term!     

What we offer 

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind. 

Contact  

Please apply to the role via our careers site, as unfortunately we don’t accept directly sent resumes. In case you wish to know more about the role and the team, don’t hesitate to reach out to Bo Maach-Møller (Sr Director, RBQM & Central monitoring) at bmlr@novonordisk.com 

Deadline  

Apply before 27 April 2026. 

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.