Advanced QA Professional - Aseptic Pilot Plant

Do you want to use your quality mindset and strong interpersonal skills to make a difference within Quality Assurance? Are you eager to play an important role in ensuring a high-quality pilot facility and contribute to the qualification of utility, equipment, and implementation of a new filling line for clinical development products? If so, this position as Advanced QA Professional may be just what you are looking for.

In CMC Development we make a difference for patients with chronic diseases across the world as we develop, manufacture, and distribute drug candidates for clinical trials. Our CMC Development/CMC QA department is an ambitious organisation with a strong culture, that always seek to solve problems, an eye for the entire business and do the best to deliver despite any obstacles along the way. We have a high focus on delivering high quality to our customers which is why we are looking for a dedicated professional to help us with that. Read more and apply for a life-changing career with us today!

The position

You will ensure that all GMP activities at our aseptic pilot plant are in control and the facility is compliant for clinical batch production. You will challenge and approve documents related to development and manufacture, as well as qualification and validation activities. Currently, we are re-building the facility to implement an isolator, which will involve numerous projects and validation activities. Your daily work will primarily be in Måløv, with occasional meetings and training in Bagsværd or other sites in Greater Copenhagen. If you are skilled within aseptic manufacturing processes, pre-assessments and audits of new and existing CMOs can also be part of your job. You will be:

• Assuring quality of Aseptic production in line with the GMP regulations and that the facility is compliant.
• Challenging and approving documents related to development, manufacture, qualification, and validation.
• Participating in multiple projects and validation activities.
• When skilled within aseptic manufacturing processes, conducting pre-assessments and audits of new and existing CMOs.

Qualifications

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, making decisions and following up on quality related problems. We are looking for someone with:

• A Master’s degree in Pharmacy, Engineering, Biology, Chemistry, or similar discipline.
• Industrial experience with GMP and quality assurance, ideally from building projects and/or validation of production lines.
• Good understanding/experience with regulations, requirements, and guidelines for pharmaceutical development and production.
• Experience with aseptic production is an advantage. It will also be advantageous if you are trained/ have knowledge within SRV.
• As we operate in both national and international environments, you should be able to speak and write in English and Danish fluently. However, we are happy to receive your application also if you are currently at an upper intermediate level and in the process of taking advanced Danish courses.

On a personal level, you need to be a self-driven and independent person with a high sense of responsibility and initiative who can prioritise your many different tasks. You thrive in a dynamic environment, where teamwork is on the top of the agenda, and like working with many different stakeholders.

About the department

You will join the CMC Development QA department, consisting of more than 35 dedicated colleagues across three teams. Our main purpose is to safeguard patient safety and ensure product quality and compliance. As part of Novo Nordisk Quality, we support the business and strive for simplicity every day, ensuring Novo Nordisk’s critical delivery of medicines to patients.

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 Marianne Mørch Hansen +45 3079 8154.

Deadline

09 April 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.