QA Specialist

Bavarian Nordic; Kvistgård; On-site; DKK 550,000 - 750,000; Full time

Job summary

Bavarian Nordic is seeking a QA Specialist to support QA for QC, Raw Materials and Warehouse in Kvistgård, Denmark. The role focuses on ensuring GMP-compliant deviations, change controls, and investigations across analytical methods and equipment qualifications.

You will work closely with cross-functional teams in an international environment, contributing to quality assurance and continuous improvement while maintaining strict regulatory standards.

Qualifications

• A relevant MSc degree in Life Sciences or related field is required.
• Solid GMP knowledge is essential for quality assurance.
• Experience with QA processes and regulatory expectations is preferred.
• Fluent in English, both written and spoken.

Responsibilities

• Review and approve SOPs, Change Control, Deviations and CAPAs in Veeva.
• Handle Out-of-Specification (OOS) investigations and laboratory investigations.
• Review and approve protocols and reports for Analytical Method Validation and Equipment Qualification.
• Support stability protocols and reports, and participate in related projects.
• Contribute to continuous improvement activities and QA oversight.
• Collaborate with international teams to ensure compliance and timely releases.

Skills

GMP knowledge

QA experience

Stakeholder management

English proficiency

Education

MSc in Life Sciences

Tools

Veeva

Job description

Are you ready to make a difference in global health by ensuring the highest quality standards in vaccine production, contributing to the mission of saving lives?

We are looking for our new QA Specialist supporting QC. A broad role covering many different aspects. If this sounds interesting to you, then continue reading!

About The Team

The QA Operations organization consists of 45 employees, 5 managers, and one director. You will be part of the dynamic QA for QC, Raw Materials, and Warehouse team which consists of 8 employees in Germany (2) and Denmark (6). The team supports QC with processing of deviations, change controls, laboratory investigations, stability, validation and qualification of analytical methods and equipment as well as the release of Raw Materials and Secondary Packaging Materials for use in Production.

You will report to the Manager for QA for QC, Raw Materials and Warehouse. The position is based in Denmark and requires you to be mainly on-site in Kvistgaard.

"As a leader, I believe in an open-door policy built on accessibility and transparency. I’m deeply committed to supporting my team's growth and well-being while creating a positive environment where we can grow and succeed together. My goal is for every employee to feel valued, empowered, and understand the important role they play in BN's production success." - Says Dorthe Tarnø, Manager for QA for QC, Raw Materials and Warehouse.

Your impact

• Review and approve SOPs, Change Control, Deviations and CAPAs in Veeva
• Handling of Out-of-Specification (OOS) and Laboratory Investigations
• Review and approval of protocols and reports for Analytical Method Validation and Equipment Qualification as well as supporting related projects
• Review and approval of Stability protocols and reports
• Continuous Improvement activities
• QA Oversight

Are you our next pioneer?

Succeeding with our vision of becoming one of the largest pure-play vaccine companies in the world is no walk in the park, and that is why we need people like you who are determined to make it happen and have the following qualifications:

• A relevant MSc degree (Pharmacology, Biochemistry, Microbiology, Life Sciences, or similar)
• A minimum of 3-5 years of experience from a similar position as QA
• Solid GMP knowledge
• Experience with Quality Risk Management and Systematic Problem Solving
• Fluency in English, both written and verbal

About You

You have excellent stakeholder management and collaboration skills, strong communication, and a proactive, open-minded approach.

You are decisive, and optimistic in problem-solving, with a drive to achieve goals and manage changing priorities in fast-paced settings. Adaptable, flexible, and resilient, you thrive in dynamic environments, balancing quality with pragmatic solutions.

You are accountable, detail-oriented, and confident working both independently and in teams, especially in international contexts.

Why join us?

• We offer great collegiality, and daily team meets to ensure alignment and support to team members
• As we continue to grow, you will have a unique opportunity to make a real impact, shaping both the team and our QA processes
• Opportunity to take part in exciting projects supporting QC, including the insourcing of QC release testing, with the chance to be a key driver in analytical method validation initiatives
• We provide an international environment where personal and professional growth is highly prioritized
• Become part of a team that directly contributes to global health by manufacturing and developing life-saving vaccines
• Enjoy a vibrant staff club that offers a variety of diverse 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

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 at Bavarian Nordic. We are a fully integrated vaccine company focused on the development, manufacturing and commercialisation of life-saving vaccines, and the largest pure-play vaccine company in the world.

Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America.

Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

For more information, visit www.bavarian-nordic.com