Quality Specialist in R&D Quality

Are you passionate about quality and process simplification? Do you want to build quality within processes in the most efficient way and you like to take initiative and drive change for your colleagues and stakeholders? Then join us, as our new Quality Specialist within Regulatory – Labelling processes.

The position

The Quality Specialist position is in the Quality department for Global Patient Safety (GPS) & Regulatory Affairs (RA) based in Søborg, Denmark. Here we support the GPS and RA areas in many aspects of quality and there is a strong need for quality support as Process QA Delegate and Quality partner in labelling processes and projects.

As a Quality Specialist, your core responsibilities will include:

• Process QA delegate for the Labelling process:
  • Oversee that the process is compliant with regulatory requirements and QMS
  • Participate in the process review with focus on process compliance and simplicity
  • Partner with the process manager in driving process group activities as relevant
  • Design future processes in Regulatory Affairs together with the process owner and process experts
• Quality advisor specialist for RA and RA IT projects
  • QA for Deviations, Change requests, SOPs, Inspections and audits
  • Provide GxP advice and support to the organisation and support IT transformation projects to ensure implementation or update of RA systems
  • Coach, support and train R&D Quality colleagues, and key stakeholders 
• Lead and manage quality improvement projects and initiatives in R&D Quality to ensure the right level of compliance, readiness, and ownership around the optimisations to come
• Active member of the Secondary Packaging Material Focus group - be topic lead of compliance signals and ensure timeliness implementation

You will be part of a dynamic area, where the position offers high impact, and where you are expected to take ownership and responsibility for setting the right quality level in the global organisation. 

Qualifications
As a person you approach problem-solving with a positive and practical mindset, always seeking opportunities to optimise and simplify processes. Your proactive and courageous nature is complemented by your excellent communication and interpersonal abilities. 

We're looking for candidates who bring these qualifications:

• An academic degree in science, pharmacy, biology, or similar
• A minimum of 6+ years of working experience within quality assurance or quality management processes with extensive experience with quality requirements (GxP), ISO13485, and other relevant regulations in the pharmaceutical industry 
• Preferred qualifications include experience with continuous improvement methods like Six Sigma / cLEAN, experience with Quality Risk Management 
• Experience within Regulatory processes like labelling, submission and registration is an advantage
• Proficiency in both written and spoken English

Additionally, you possess a strong sense of organisation and attention to detail without losing sight of the broader picture. Your commitment to quality is unwavering, and your innate curiosity drives your continuous learning. You excel as both a collaborative team member and an independent worker, thriving in cross-departmental collaborations within an international organisation.  
 
About the department

Global Safety and Regulatory Affairs Quality is one of three sister departments in Research and Development Quality Operation, which is part of R&D Quality in Novo Nordisk. We are a very diverse quality department that supports a large organization and with global stakeholder interaction. 

In GS & RA Quality we offer Quality Management System expertise for our stakeholders and play a vital role in ensuring high-quality fit-for-purpose processes throughout the value chain.

As we also take an active part in cross-organisational improvement projects and provide general quality and compliance support to our global organisation, we are on an exciting journey bringing quality to the top of the agenda throughout the organisation for the benefit of our patients.

Working at Novo Nordisk

We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research to our rich personal lives that motivate and energize us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.  

Contact

For further information, please contact Lavinia M. Pedersen at +45 30799636. 

Deadline

9 of March 2025.

To ensure an efficient and fair recruitment process, please refrain from adding a photo to 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.