Bavarian Nordic

General

• Develop, qualify and improve global transport and cold chain distribution solutions compliant with GDP
• Provide practical guidance on cold chain requirements as a subject matter expert
• Lead transport validation and qualification activities, including protocols, performance qualifications, reports, periodic reviews and risk assessments
• Support audits, inspections and assessments
• Support qualification and ongoing assessment of logistics suppliers and transport solutions
• Define and address distribution and qualification requirements for new product introductions and distribution lanes
• Manage and assess temperature excursions using relevant stability data when required
• Own deviations, change controls and CAPAs related to distribution and cold chain activities
• Investigate root causes, coordinate stakeholder actions and follow through on implementation and effectiveness
• Translate recurring issues and operational insights into improvements
• Assess and implement global cold chain monitoring and data management systems
• Develop and maintain dashboards, KPIs and analytics frameworks
• Analyze data to identify trends and emerging risks and prepare actionable insights for management reviews and governance meetings
• Collaborate with Digital, IT, Quality and Supply Chain to improve digital platforms, automate reporting and strengthen data quality
• Evaluate and support AI-enabled solutions, predictive analytics, intelligent automation, digital simulation and connected monitoring technologies
• Support data governance, data integrity and validation requirements for GxP-relevant digital systems

Global Distribution Validation – Cold Chain Specialist