GMP Specialist

Bavarian Nordic A/S; Kvistgård; On-site; DKK 700,000 - 1,000,000; Full time

Job summary

Bavarian Nordic is seeking a Site Supply Chain professional in Kvistgård to lead deviation investigations, CAPAs and the strengthening of our SOP landscape. You will partner with QA, Warehouse and cross-functional teams to ensure inspections readiness and robust, compliant processes that keep materials flowing.

The role offers a real opportunity to shape the function as our Site Supply Chain evolves, delivering practical improvements while maintaining GMP/GDP standards and regulatory alignment.

Qualifications

• Degree in a relevant scientific discipline and experience in regulated environments.
• Hands-on ownership of deviations, change controls and CAPAs.
• Experience in internal audits and regulatory inspections.
• LEAN or continuous improvement experience; belt level advantageous.
• Working knowledge of ERP systems (D365 F&O or similar).
• Fluent Danish and English with strong technical writing skills.
• Power BI experience is a plus.
• Proactive, structured mindset with ability to drive initiatives to completion.
• Ability to work independently within GMP/GDP requirements.

Responsibilities

• Drive deviation investigations from identification to CAPA implementation and closure.
• Own and strengthen the SOP landscape for warehouse and supply chain processes.
• Identify gaps and drive process optimization without compromising quality.
• Support internal audits and regulatory inspections; act as site representative for warehouse compliance.
• Bridge regulatory requirements to daily operations and ensure inspection readiness.
• Collaborate across functions to build a quality-focused, continuous-improvement culture.

Skills

Deviation ownership

CAPA management

Audit readiness

LEAN / CI

Power BI

ERP systems

Technical writing

Independent decision making

Structured mindset

Regulatory experience

Education

Bachelor's degree in Pharmacy, Engineering, Biochemistry, Microbiology or related field

Tools

D365 F&O

Job description

Can you investigate a deviation and get to the real root cause? Do you get satisfaction from improving a process without compromising quality? And would you rather help build and improve something than simply maintain it?

Then you may be the person we are looking for at Bavarian Nordic in Kvistgaard.

You will drive deviation investigations, strengthen our SOP landscape, support audit and inspection readiness, and identify and implement improvements that make our daily operations more robust and efficient.

You will report directly to the Head of Site Supply Chain and work closely with our Warehouse Manager, warehouse operators, QA and colleagues across the site.

As this is a newly created position, you will have a real opportunity to shape the role and contribute to the continued development of our warehouse operations.

What you will do

Drive deviation investigations and CAPAs

You will drive deviations related to warehouse and supply chain processes from identification and classification through structured root cause investigation and impact assessment to CAPA definition and follow-up.

You will ensure investigations progress to closure and that conclusions and actions are technically sound, well documented and inspection-ready.

You will work closely with Warehouse, QA and relevant stakeholders to ensure that corrective and preventive actions address the actual root cause and deliver sustainable improvements.

Own and strengthen our SOP landscape

You will take an active ownership role in the SOP landscape for warehouse and relevant supply chain processes.

This includes writing new procedures, revising existing ones, coordinating periodic reviews and ensuring that our procedures reflect both regulatory requirements and the way we operate.

You will also help ensure that training curricula and relevant system reviews remain current and effective.

Drive process optimization

Compliance and efficiency should reinforce each other.

You will identify gaps, risks and bottlenecks, and turn them into practical improvement initiatives without compromising the quality requirements under which we operate.

You will drive improvements from initial idea and root cause through implementation and embedding into daily operations.

Audit and inspection readiness

You will support preparation for internal audits and regulatory inspections and participate as a key Supply Chain representative for warehouse-related compliance topics.

You will coordinate follow-up activities and help ensure that we remain inspection-ready — not only when an inspection is approaching, but as part of our everyday way of working.

You will act as the bridge between regulatory requirements and daily operations.

You can translate complex GMP and GDP requirements into practical solutions that warehouse operators, managers, QA and other business stakeholders can understand and work with.

You will collaborate across functions and levels of the organization and contribute to building a strong quality and continuous-improvement culture within Site Supply Chain.

What we are looking for

• A degree in Pharmacy, Engineering, Biochemistry, Microbiology, or another relevant scientific discipline
• Experience from a regulated environment such as pharmaceuticals, biotechnology, medical devices, food production, or a similar industry
• Hands-on experience owning deviations, change controls and CAPAs independently
• Experience participating in internal audits and regulatory inspections
• Experience with LEAN or continuous improvement. Yellow or Green Belt is an advantage
• Working knowledge of ERP systems (D365 F&O or similar)
• Fluent in Danish and English, written and spoken, with strong technical writing skills
• Experience with Power BI is an advantage
• A proactive and structured mindset, combined with the ability to follow initiatives through to completion
• Confidence working independently and making decisions within established procedures and quality requirements

Experience from warehouse, logistics, supply chain or material handling within a GMP/GDP environment would be a strong advantage.

What will make you successful

You will work closely with colleagues across our entire site, so being constructive, pragmatic and approachable matters — also on busy days.

You enjoy being close to operations, asking the extra question when something does not make sense and finding solutions that work in practice as well as on paper.

Success in this role ultimately means creating a compliant, robust and efficient warehouse operation that keeps materials flowing.

And because this is a newly created role, you will have the opportunity to influence how it develops as our Site Supply Chain organization and warehouse operations continue to evolve.

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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Location: Kvistgaard - Hejreskovvej 10A