QA Specialist, Drug Product

Bavarian Nordic A/S; Denmark; Hybrid; DKK 700,000 - 900,000; Full time

Benefits offered by this job

Competitive salary

Pension

Health insurance

Bonus opportunity

Employee benefits

Flexible work arrangements

Canteen and staff club

Job summary

Bavarian Nordic in Kvistgård, Denmark, is seeking an experienced QA Specialist to strengthen the QA Drug Product team and drive quality, compliance, and continuous improvement across manufacturing operations.

The role involves QA direction, oversight of deviations and CAPAs, and collaboration with production and cross-functional teams to ensure timely product disposition and inspection readiness.

Qualifications

• Degree in Life Sciences, Pharmacy, Engineering, or related discipline.
• Typically 5+ years of QA experience in pharma/biotech/vaccine manufacturing.
• Strong GMP, Process Validation, QMS knowledge.
• Experience leading complex quality activities and cross-functional projects.
• English and Danish proficiency required.

Responsibilities

• Provide QA direction to Production and cross-functional stakeholders.
• Review and approve Deviations, CAPAs, Change Controls, batch documentation and SOPs.
• Perform QA oversight of Drug Product manufacturing and product disposition.
• Lead investigations and quality risk management to identify compliant solutions.
• Support inspection readiness and participate in audits and other compliance activities.
• Represent QA in cross-functional projects and improvement initiatives.

Skills

QA experience

GMP knowledge

Process Validation

QMS knowledge

Regulatory knowledge

Risk-based decision making

English & Danish

Education

Life Sciences degree

Job description

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 responsibilities

• 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

• 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?

• 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.

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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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.