Area Specialist for QA for QC

Are you passionate about setting direction within emerging technologies and ensuring compliance? Do you have experience within Quality Control? Are you skilled in navigating complex stakeholder landscapes and motivating teams to deliver great results? 

If so, we have an exciting opportunity for you. 

The position
In close cooperation with your colleagues, you act as a QA for QC servicing our QC and CMO (contract manufacturing operations) laboratories. You contribute to finding solutions for ad hoc questions and challenges within compliance of QC laboratories. Your main task will be approving the documentation needed for the operation of the laboratories such as change requests, deviations and SOP’s.  
Furthermore, you will assist your colleagues in assuring qualification of laboratory equipment and validation of methods for analysis of drug product for the market are compliant with internal and external requirements.
Our continuing high level of audit and inspection readiness is on top on your agenda. This means that in QA we work with QA oversight where you are proactive, together with your colleagues, and will identify areas where our compliance can be strengthened.
You have a risk-based approach to the quality control process and product, and you contribute to find the right balance between patient safety, compliance to requirements and effective business conduct.
Drive local and/or cross-functional initiatives to support ET Quality and stakeholders’ strategic initiatives.

Qualifications
To be considered for this position, we expect you to:

• You hold an academic degree as pharmacist, engineer or similar.
• You have at least +6 years of experience from a pharmaceutical or medical device organization, where you have gained a solid and up-to-date knowledge of quality and GMP requirements.
• Have excellent stakeholder management skills, even in addressing complex matters and tough decisions 
• Be fluent in both spoken and written English.
• It will be considered an advantage if you are proficient in Danish.

The ideal candidate has thorough knowledge within analysis validation, analysis equipment qualification, flair for automation and software, project management, as well as laboratory computer system validation. CMO (contract manufacturing operations) is a plus.
As a person, you have excellent relationship building skills and a positive attitude. You are curious and interested in understanding complex processes and consider multiple perspectives. 
The most important asset that you can bring to succeed in this job is a well-developed understanding of quality and a natural urge to handle quality issues at the right level, make decisions and follow-up on quality related problems. You are a self-motivated and independent person with a high level of responsibility and initiative who can prioritize your various tasks.
You enjoy working in a dynamic environment, where teamwork is essential, and you like collaborating with many different stakeholders – 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 ambitious 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 +45 30752316.

Deadline
5 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.
Applications will be evaluated continuously when received, and candidates may be called for interview before the deadline.

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.