Global Distribution Validation & Cold Chain Specialist

Bavarian Nordic is seeking a Global Distribution Validation & Cold Chain Specialist to enhance their global vaccine distribution. The company specializes in developing and delivering vaccines, ensuring they are transported under optimal conditions. This role is crucial for maintaining compliance with Good Distribution Practice (GDP) and leveraging digital tools to improve cold chain performance. The main responsibilities of this role include developing, qualifying, and improving global transport and cold chain distribution solutions. This involves planning and executing transport validation and qualification activities, such as protocols, performance qualifications (PQs), and risk assessments. The specialist will also act as a subject matter expert, providing guidance on cold chain requirements and supporting audits and inspections. Additionally, the role involves managing temperature excursions, owning deviations, and driving improvements in cold chain performance and compliance. To qualify for this position, candidates must have a bachelor's or master's degree in Life Sciences, Engineering, Supply Chain, Logistics, or a related discipline. At least five years of relevant experience in pharmaceutical distribution, validation, cold chain management, or a related regulated environment is required. Strong knowledge of GMP/GDP guidelines and practical application to transport and cold chain activities is essential. Hands-on experience with transport validation and qualification, including protocols, PQs, risk assessments, and periodic reviews, is also necessary. Experience assessing temperature excursions and managing deviations, change controls, and CAPAs is crucial. Nice-to-have skills include experience with logistics supplier qualification and distribution support for new product introductions. Familiarity with AI, predictive analytics, or digital transformation initiatives is also valuable. Knowledge of computerized systems, data integrity principles, and validation of GxP-relevant digital solutions is an advantage. The role is based in Denmark or Switzerland and involves travel. The team at Bavarian Nordic values ownership and systematic problem-solving. The specialist will work closely with various departments, including Quality, Supply Chain, Digital, and IT, to implement digital platforms and strengthen data quality. The role offers the opportunity to influence global vaccine distribution and contribute to the development of stronger monitoring and digital capabilities. What the role asks for: - Bachelor's or master's degree in Life Sciences, Engineering, Supply Chain, Logistics or related discipline. - At least five years of relevant experience in pharmaceutical distribution, validation, cold chain management or a related regulated environment. - Strong knowledge of GMP/GDP guidelines and their practical application to transport and cold chain activities. - Hands-on experience with transport validation and qualification, including protocols, PQs, risk assessments and periodic reviews. - Experience assessing temperature excursions and managing deviations, change controls and CAPAs. - Experience with Power BI, Tableau, Qlik or similar analytics tools. - Familiarity with AI, predictive analytics or digital transformation initiatives (nice-to-have).