Quality Specialist with expertise within In-Vitro Diagnostics
6 days ago
Category: Quality
Location: Søborg, Capital Region of Denmark, DK
Do you want to be at the forefront of innovation by setting direction for quality standards in diagnostics? Do you want to use your solid in vitro diagnostics (IVD) knowledge and experience in making sure that we continuously live up to IVD regulatory requirements? If yes, we might have a perfect role for you since we are searching for an IVD medical device Quality Specialist with a ‘can do’ attitude and quality mind-set to support Novo Nordisk in this exciting journey.
The position
The role focuses on acting as a Quality Partner for key projects involving IVD solutions, with responsibilities spanning collaboration, training, and cross-organizational communication. It requires a strategic mindset, a high degree of independence, and expertise in Quality Management Systems.
Your main responsibilities include:
- Ensuring compliance with IVD regulations and other relevant requirements.
- Acting as a Quality Partner and supporting key projects with IVD solutions.
- Collaborating with cross-functional teams and participating in strategic, cross-organizational projects.
- Expanding organizational knowledge within the IVD medical device area.
- Providing QA support across Research & Development, including Quality Risk Management, Change Control, and Deviations.
Qualifications
You are expected to take part in the development of the area, be curious and proactive in identifying best practices, and drive change across the organisation. You will continuously improve the quality mind-set within Novo Nordisk whilst ensuring we have competitive speed and flexibility to meet our business needs.
To be successful in your application:
- You hold a Master of Science degree within natural sciences (e.g., Pharmacy, Chemistry, Biology) with 6–8 years of experience in quality assurance, regulatory, or clinical affairs.
- You have strong knowledge of regulatory requirements for IVD, including IVD regulations and relevant ISO standards, and their application to pharmaceutical IVD medical devices.
- You are experienced in maintaining a Quality Management System, participating in supplier qualifications, audits and inspections, and fluent in written and spoken English.
- You are familiar with project management and possess a 'can do' mindset to explore innovative ideas and new ways of working.
- You have a proven ability to set direction, propose compliant solutions aligned with business needs, and identify opportunities with a structured approach.
On a personal level, your excellent communication and stakeholder management skills enable you to liaise across all organizational levels, geographies, and cultures. Moreover, you are a team player with strong interpersonal skills, highly engaged, resilient in facing challenges, and willing to take responsibility. You are courageous, innovative, strive for simplicity, and demonstrate a risk-based, solution-oriented approach.
About the department
The role as Quality Specialist with expertise within In-Vitro Diagnostics Regulations (IVDR) is anchored in RDQ Operational Excellence which is one of four departments within R&D Quality Operations in Development. We are now looking for expertise in the evolving area of IVD solutions in our development programs. The department is committed to the continuous improvement and simplification of the Quality Management System (QMS). Our team consists of 10 highly skilled individuals with different roles and responsibilities, specializing in enhancing GxP processes.
Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we are all working to move the needle on patient care.
Contact
Deadline: 26 January 2025
To ensure an efficient and fair recruitment process, please refrain from adding a photo in 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.
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