Quality Systems & Compliance Manager

Are you a driven professional with a passion for quality management and regulatory compliance? Are you motivated by building and leading your own team while creating a new, locally managed quality function?

Then we have an exciting opportunity for you as a Quality Systems & Compliance Manager.

Join our team and let's make a difference together
You will have the opportunity to build and lead your own team of three senior process owners, each specializing in key areas: audits and inspections, deviation and CAPA management, and change control and continuous improvements. Together, you will work on critical aspects of quality assurance, driving excellence and compliance across the organization.

The position is located in Kvistgaard and you will be reporting to the Head of site, QA.

Your Impact
In this role, you will be at the forefront of developing, maintaining, and improving our Quality Management System (QMS) while fostering a culture of excellence across the organization.

Your key tasks and responsibilities:

• Lead and manage a team, fostering collaboration and ensuring quality objectives and compliance goals are met
• Develop and maintain the QMS in compliance with GMP and global standards, ensuring documentation is updated and effective
• Ensure compliance and coordinate internal and external audits, monitor QMS-related metrics, and manage corrective actions to uphold regulatory compliance
• Conduct risk assessments, identify quality risks in manufacturing processes, implement mitigation strategies, and promote a risk-based approach across the production cycle
• Drive continuous improvement by leading initiatives to optimize QMS efficiency, promote a culture of quality, and report performance metrics, risk areas, and opportunities for improvement

Are you our next pioneer?
To succeed in this role you will need:

• A scientific master´s degree e.g. microbiologist, engineer, pharmacist, or similar
• In-depth understanding of QMS, regulatory guidelines, and industry standards
• Demonstrated expertise in quality systems and regulatory compliance within GMP-regulated industries such as pharmaceuticals, biotechnology, or manufacturing
• Proven experience in leading teams and managing cross-functional projects expertise in risk management and continuous improvement methodologies
• Proficiency in English. Danish is a plus

About you
We are seeking a collaborative candidate with exceptional communication skills, a sharp ability to quickly understand processes, and the talent to clearly explain workflows. The ideal candidate will have a strong foundation in pharmaceutical quality systems, a passion for educating others, and a proven ability to drive improvements, foster collaboration across teams, and successfully lead a small team of specialists.

Why join us?

• This role provides an exceptional chance to gain in-depth experience with end-to-end vaccine manufacturing processes, touching every aspect of production and quality assurance
• We have a dynamic and collaborative work environment
• You can make a significant impact on the quality and compliance landscape within our organization
• You will have opportunities for professional growth and development, all leaders will attend a developing leadership training program by LeadPioneers
• Enjoy a vibrant staff club that offers a variety of diverse and exciting events
• We provide charging stations for electric vehicles at our facilities in Kvistgaard
• Convenient bus route (70E) from Humlebæk Station directly to our Kvistgaard facilities

At Bavarian Nordic, we are dedicated to saving and improving lives through the development and sale of innovative vaccines. As a rapidly growing company with a burning vision to become a market leader in vaccine manufacturing, we offer a unique opportunity to contribute to a meaningful mission. You will work in an open environment where we 'walk the talk,' enjoy a wide range of responsibilities and benefit from quick decision-making processes and opportunities for personal growth.

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. Due to the upcoming Christmas holidays, our recruitment team will have limited availability. While we are excited to review your application, we kindly ask for your patience as responses may be delayed until after the holiday season.

Please contact Cornelia Nickenig, Head of Site, QA at + 45 21 70 22 63, if you have any questions about the role.

Join us and become part of a diverse team dedicated to making a difference together.

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.

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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/

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Location: Kvistgaard - Hejreskovvej 10A