Senior QA Professional - Emerging Technologies QA

Are you driven by the opportunity to shape the future of emerging technologies, ensure compliance, and contribute to new acquisitions? Do you thrive in a role with diverse professional interfaces and projects with many stakeholders across Novo Nordisk and at our CMOs?

If you’re ready to take your expertise in QC processes further and join a motivated, supportive team, we look forward to welcoming you in our dynamic Emerging Technologies QA (ET QA) department. Apply now!

The position

As a Senior QA Professional and in close cooperation with your colleagues, you act as a QA expert for QC servicing our internal and external QC laboratories. You contribute to finding solutions for ad hoc questions and challenges within compliance of QC laboratories.

In this position you will also be the QA responsible for the analytical methods implemented at Novo Nordisk CMO's. You will participate in projects working with both internal and external stakeholders and you must expect a level of complexity and independent decision-making in your daily tasks.
Your primary responsibilities includes:

• Approving the documentation needed for the operation of the laboratories such as change requests, deviations, and SOP’s
• Driving QA review and approval of analytical documentation such as protocols and reports for method validation from NN site and CMOs
• Supporting analytical activities from phase 3 clinical studies throughout commercial life cycle
• Keeping up to date with changes in relevant guidelines and regulatory requirements

Furthermore, you will assist your colleagues in assuring qualification of laboratory equipment and validation of methods for analysis of drug substance and product for the market are compliant with internal and external requirements.

Qualifications
To succeed in this role, you:

• Hold an academic degree as Pharmacist, Chemist, Engineer, or similar
• Bring at least 5 years of experience within analysis validation, equipment qualification, method transfer, ideally within the pharma industry
• Have a solid and up-to date knowledge of quality and GMP requirements
• Demonstrate excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment while redefining the status quo
• Showcase fluency in both spoken and written English

It would be considered as a strong advantage if you have CMO experience, along with a flair for automation, project management, as well as laboratory computer system validation.

Additionally, proficiency in Danish is a plus.

On a personal level, you have a well-developed understanding of quality and a proactive approach to addressing quality issues. You confidently make decisions, adeptly balancing quality demands, authority expectations, and business needs. You have an open-minded and outgoing attitude with natural networking skills, taking ownership of your work and thriving in a collaborative environment as well as on your own. You enjoy working in a dynamic environment, where teamwork is essential, and you like partnering with many different stakeholders – both internally and externally.
 

About the department

ET QA New Entry & Support is a department with approximately 30 skilled and motivated colleagues. We handle new and emerging technologies for Novo Nordisk's product portfolio as well as supporting the rest of QA and production. We are proud to work in a fast-growing and committed part of Novo Nordisk.

We are a diverse and agile team of QA professionals who work closely with internal and external partners to ensure quality and compliance throughout the product lifecycle. We are always looking for new ways to improve our processes and practices, and we embrace the cLEAN culture and mindset.

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’re all working to move the needle on patient care.

Contact

For further information, please contact Manager Semra Nur Canbaz at +45 30752316.

Deadline

27 January 2025.

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. 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.