Live opening · Posted 4 days ago

QA Specialist, Drug Product

Bavarian Nordic Berna GmbH · Kvistgaard
Workday
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At a glance

The key details from the original listing.

Posted 4 days ago
CompanyBavarian Nordic Berna GmbH
LocationKvistgaard
SourceWorkday
ListedPosted 4 days ago

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About the role

Description supplied by the original job listing.

Help shape quality and protect lives through vaccines
Are you an experienced QA Specialist who can navigate complexity, influence stakeholders, and create progress in a dynamic manufacturing environment?
At Bavarian Nordic in Kvistgaard, we develop and manufacture life-saving vaccines that protect people around the world.
We are looking for a QA Specialist to join our QA Drug Product team and help strengthen quality, compliance, and continuous improvement across our manufacturing operations.
Your role
As a QA Specialist, you will work closely with Production and other functions to provide clear quality direction, resolve complex issues, and ensure that critical activities progress in a compliant and timely manner.
You will manage a varied portfolio of operational QA activities, investigations, and improvement initiatives, often with competing priorities and deadlines. You must therefore be able to maintain an overview, make sound risk-based decisions, and drive activities through to completion.
This is an individual-contributor role without formal people-management responsibility. You will lead through expertise, credibility, and influence, building alignment while maintaining an independent QA position.
You will report to the Head of QA Drug Product and join a skilled and collaborative team committed to quality excellence, knowledge sharing, and patient safety.
Your responsibilities
As a QA Specialist, you will:
Provide clear QA direction and trusted advice to Production and cross-functional stakeholders
Review and approve Deviations, CAPAs, Change Controls, batch documentation, SOPs, and other GMP-relevant records within your delegated authority
Perform QA oversight of Drug Product manufacturing and support timely product disposition
Lead the resolution of complex quality issues and investigations
Apply quality risk management to identify pragmatic and compliant solutions
Represent QA in cross-functional projects, forums, and improvement initiatives
Identify quality and compliance risks and ensure timely escalation and follow-up
Support inspection readiness and represent QA during inspections, audits, and other significant compliance activities
Improve quality processes, standards, and ways of working
Share knowledge and contribute to a strong and proactive quality culture
What you bring
We expect you to have:
A relevant degree in Life Sciences, Pharmacy, Engineering, or a related discipline
Typically, five or more years of relevant QA experience within pharmaceutical, biotechnology, or vaccine manufacturing
Strong knowledge of GMP, Process Validation, QMS, and applicable regulatory expectations
Experience leading complex quality activities, investigations, or cross-functional projects
A broad understanding of pharmaceutical manufacturing processes and cross-functional dependencies
The ability to manage several priorities, deadlines, and stakeholders simultaneously
Strong risk-based decision-making and problem-solving skills
Professional proficiency in English and Danish is a requirement
How you work
You establish credibility through your expertise, judgement, and consistent delivery. You communicate clearly and diplomatically, listen to different perspectives, and build commitment without relying on formal authority.
You remain calm and effective when priorities change, constructively challenge decisions when quality or compliance may be at risk, and move activities forward even when the situation is complex or information is incomplete.
About the team and department
You will join a competent and supportive QA Drug Product team. The team currently consists of six colleagues and will grow to seven with this hire. The group represents a healthy mix of experienced QA specialists, fostering collaboration, knowledge sharing, and continuous development.
You will also become part of our QA Operations department, comprising approximately 40 employees across sites in Kvistgaard, Denmark, and Munich, Germany. The department is characterized by close cross-site collaboration, a strong quality mindset, and a shared commitment to delivering safe and compliant products to patients.
Why join Bavarian Nordic?
At Bavarian Nordic, your work will contribute directly to the development and production of life-saving vaccines. We offer:
Meaningful work with an impact on patients and global health
A collaborative, inclusive, and international working environment
A broad role with significant cross-functional interaction
Opportunities for professional and personal development
Competitive salary, pension, health insurance, bonus opportunity, and employee benefits
Flexible working arrangements combining on-site and remote work, depending on the activities involved
Access to our canteen, staff club, fitness benefits, EV charging stations, and convenient transportation options
For us, it is all about improving and saving lives together
We are a fully integrated vaccine company focused on the development, manufacturing, and commercialization of life-saving vaccines, and one of the largest pure-play vaccine companies in the world. 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.
Are you ready to join us in our mission?
If this sounds like the next step in your career, we would love to hear from you.
We look forward to receiving your application together with your CV. We are conducting interviews on an ongoing basis and encourage you to apply as soon as possible.
We kindly request that headhunters or recruitment agencies refrain from contacting us regarding this position.
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
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