QA Senior Specialist, External Manufacturing

Are you passionate about setting Quality direction and having Quality oversight at Contract Manufacturing Organizations (CMOs), taking ownership, working independently, and continuously learning and growing? Do you find purpose in a growing international business environment where we focus on saving lives every day?

Then you could be our new QA Senior Specialist in the External Manufacturing department at Kvistgaard, Denmark.

Boost our Team

We are expanding our QA External Manufacturing Department, which ensures quality assurance for outsourced production worldwide. You will join an experienced team of 8 Specialists/Senior Specialists with a flexible work culture. As a dynamic and collaborative team, we provide expert QA support and set the direction for our Global Contract Manufacturers while maintaining a great sense of humor and a down-to-earth attitude.

With our CMOs located worldwide, this role requires travel of 15+ days per year. Your primary workplace will be our manufacturing site in Kvistgaard, Denmark. Still, flexibility is key and you should be comfortable working remotely and collaborating effectively both virtually and in an office setting.

You will refer to a supportive and available leader - the Head of Quality, External Manufacturing.

Your Impact

As a QA Senior Specialist, you will be responsible for daily support, QA oversight, and GMP guidance to CMOs to ensure that our products are manufactured according to current GMP and our marketing authorizations.

You will solve a wide variety of tasks and have a great opportunity to be challenged every day. The main responsibilities are:

• QA-responsible person for the Combination Product/Device process (the process is owned by MSAT)
• Quality oversight of production and activities at the CMO with primary stakeholders
• Maintain and develop specialized knowledge within the field of responsibility
• Ensure timely review and QA-approval of CMO documents i.e. Change Controls, Deviations, Process Performance Qualification (PPQs), and any other CMO-related documents
• QA-responsible person for technical transfer and improvement projects

Are you our next pioneer?

To succeed in this position the following experience and qualifications are required:

• M.Sc. degree in pharmacy, chemistry, engineering, or similar

• +10 years of experience in a pharmaceutical organization
• Up-to-date knowledge of GxP requirements i.e. Deviations and Change Control handling, Annual Product Review (APR), Validations, and PPQ
• Knowledge of Combination Product/Device process, Drug Substance, Drug Product production, Secondary Packaging, CMO handling, technical transfer
• Proficient in English. Danish is a plus

About you

We are looking for a highly accountable and confident professional who thrives in a fast-paced, ever-changing environment. You excel at working both independently and in teams, handling complex tasks with efficiency. Strong communication, adaptability, and a collaborative mindset are essential. You take full ownership of your work, ensuring deadlines are met while managing multiple stakeholders effectively. You are comfortable making decisions and standing firm with stakeholders to ensure compliance, while also building strong relationships. With a keen eye for detail and a commitment to quality, you take pride in planning and executing tasks while maintaining a pragmatic approach to problem-solving.

Why join us?

• Be part of a team that directly contributes to global health by manufacturing and developing life-saving vaccines
• Work within a global department, managing CMOs, technical transfers, and commercial processes ensuring the highest standards are met across our worldwide operations
• Your work here has a visible and significant impact, ensuring the safety and well-being of millions
• We offer personal and professional development and training in processes
• Enjoy a vibrant staff club that offers a variety of diverse, fun, and exciting events
• We have charging stations for electric vehicles at our facilities in Kvistgaard
• Convenient bus route (70E) from Humlebæk Station directly to our Kvistgaard facilities

Ready to make a Difference? Apply Now!

Apply by clicking the ‘APPLY’ button. We are interviewing on an ongoing basis and look forward to receiving your motivated CV, where you state your motivation for applying for this particular role. A cover letter is not required.

For us, it is all about improving and saving lives

Improving and saving lives through innovative vaccines is at the heart of what we do in Bavarian Nordic. We are a fully integrated vaccine company focused on the development, manufacturing, and commercialization of life-saving vaccines, and the largest pure-play vaccine company in the world.

In Bavarian Nordic, we believe in the power of the team, and you will be part of a global team of more than +1600 dedicated employees with diverse backgrounds and viewpoints, who are bound together by our commitment to protect lives every day. We believe in creating an inclusive and flexible workplace with a strong focus on personal and professional development, because we need each other to take things further.

We operate in a world in constant flux and always explore new opportunities. So, if you are open-minded and have the willpower to succeed, we might be a perfect fit for you.

----

Founded in 1994, we have +30 years of experience developing life-saving vaccines. We are a global leader in smallpox and mpox vaccines. Our commercial product portfolio contains market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America. Our values – our Bavarian Nordic DNA, as we like to call it – are what guide our actions every day. We act as persistent pioneers, embrace change, value being boosted by the team, and believe in protecting lives every day. If that is also a part of your DNA, we invite you to join us in Bavarian Nordic! Bavarian Nordic is an Equal Opportunity Employer.
https://www.bavarian-nordic.com/

#LI-MS1

Location: Kvistgaard - Hejreskovvej 10A