Advanced QA Professional with Outsourcing Experience

Utilize your strong quality mindset and exceptional interpersonal skills to make a significant impact in Quality Assurance. This exciting opportunity as an Advanced QA Professional and QP delegate for injectable clinical trial products in CMC DP Development QA positions you at the forefront of ensuring the quality and safety of products that can transform lives.

Your new role

As an Advanced QA Professional, you will play a crucial role in ensuring the highest quality standards for our new manufacturing processes and drug products used in clinical trials. Your expertise will be essential in various aspects of development and production, as you collaborate with both internal teams and international partners.

Main tasks include:

• Being responsible for high-level quality assurance of new manufacturing processes and drug products for clinical trials.
• Challenging and approving documents related to development, manufacturing, stability, and status assignment of clinical batches produced in CMC and PS.
• Participating in pre-assessments of new CMOs and acting as a Subject Matter Expert during audits.
• Conducting quality oversight and review/release batches produced at the CMOs.

You will primarily be working in Måløv and should anticipate approximately 10 to 15 travel days per year, as we are increasingly outsourcing our clinical batch production to various international Contract Manufacturing Organisations (CMOs).

Your new department

CMC Development makes a difference for patients with chronic diseases across the world, developing, manufacturing, and distributing drug candidates for non-clinical and clinical trials.

CMC Development and CMC QA are ambitious organizations with a strong culture that always seek to solve problems, have an eye for the entire business, and do our 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 an Advanced QA Professional to take an active part in securing our quality level.

You will become part of a department consisting of three teams where we currently are more than 35 dedicated colleagues. 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 single day, to ensure Novo Nordisk’s critical delivery of medicines to patients in our clinical trials. 

Your skills and qualifications
To succeed in this role, you should:

• Hold a MSc in Pharmacy, Medicine, Veterinary Medicine, Pharmaceutical Chemistry and Technology, Chemistry or Biology.
• Fulfil the requirements from the Danish Health Authorities to become QP delegate.
• Have a minimum of 2 years of experience with GMP and quality assurance, preferably in batch release/status assignment.
• Have experience with aseptic production, which is a significant advantage.
• Ideally, have experience working with outsourcing and CMO collaboration, bringing solid knowledge to the position.
• Possess strong communication and collaboration skills, with fluency in both English and a high professional level of Danish.

To succeed in this role, you must have a solid understanding of quality, a proactive approach to addressing quality issues, and the ability to make informed decisions. You should also be knowledgeable about the regulations and guidelines governing pharmaceutical development and production, enabling you to navigate effectively.

As a self-driven and responsible individual, you excel at managing tasks independently while thriving in a dynamic, team-oriented environment. 

Working at Novo Nordisk
Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination and a constant curiosity. For over 100 years this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results.

What we offer
There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

More information
For further information, please contact Frederik Lindhardt at +45 3448 8259.
 

Deadline 
27 July 2025.  Interviews will be conducted after week 31.

Novo Nordisk is not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.