GMP Specialist

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

Job summary

Bavarian Nordic A/S in Kvistgård, Denmark, seeks a Site Supply Chain professional to lead deviation investigations, CAPA management, and SOP development within a GMP/GDP environment. The role collaborates with QA, warehouse, and cross-functional teams to strengthen compliance and operational efficiency.

You will drive root-cause analysis, implement CAPAs, and support audits and inspections to ensure a robust, inspection-ready warehouse operation.

Qualifications

• Degree in a relevant scientific field (pharmacy/engineering/biochemistry/microbiology).
• Experience in regulated pharma/biotech or similar industry.
• Hands-on ownership of deviations, change controls and CAPAs.
• Experience with internal audits and regulatory inspections.
• Lean or continuous improvement experience; Yellow/Green Belt is a plus.
• ERP knowledge (D365 FO or similar).
• Fluent Danish and English with strong technical writing.
• Power BI experience is advantageous.
• Proactive, structured mindset with independent work style.
• GMP/GDP warehouse/supply chain experience is a plus.

Responsibilities

• Drive deviation investigations and CAPAs from identification to closure.
• Own and strengthen the SOP landscape for warehouse and supply chain processes.
• Drive process optimization balancing compliance and efficiency.
• Support audit and inspection readiness and act as bridge for regulatory requirements.

Skills

Deviation ownership

CAPA management

LEAN/CI

ERP (D365 F&O)

Power BI

Technical writing

Education

Degree in Pharmacy, Engineering, Biochemistry or Microbiology

Tools

ERP (D365 F&O)

Power BI

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

#LI-MO1 Join Bavarian Nordic a fully integrated vaccine company focused on the development, manufacturing and commercialization of life-savings vaccines 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. All qualified applications will receive consideration for employment and will not be discriminated against on the basis of race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

For more information visit www.bavarian-nordic.com