Senior Specialist, Transportation Validation (Biotechnology, Copenhagen)

Job summary

The role focuses on ensuring safe and compliant transportation of antibody products within a global supply chain. The Senior Specialist will lead the qualification and validation of transport solutions while driving continuous improvement in adherence to regulatory standards.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Engineering, Supply Chain, or a related field.
• Over 5 years of experience in transportation validation, cold chain logistics, or pharmaceutical distribution.
• Strong knowledge of GxP and global regulatory requirements for distribution.
• Experience with equipment qualification and validation lifecycle (URS, IQ/OQ/PQ).
• Experience working with contract manufacturing organizations (CMOs) and logistics service providers in a global context.

Responsibilities

• Lead the qualification of shipping solutions and transportation equipment in collaboration with cross-functional teams.
• Drive validation of shipping lanes for intermediates and finished goods across the global commercial network.
• Ensure transportation solutions meet product requirements and regulatory standards.
• Plan and execute qualification activities for transportation equipment, ensuring robust performance documentation.
• Develop, maintain, and improve SOPs governing transportation validation and distribution activities.
• Conduct risk assessments to identify and mitigate supply chain risks.
• Author and review validation documentation in compliance with internal and regulatory requirements.
• Collaborate with vendors and stakeholders to ensure effective distribution solutions.
• Partner with Quality Assurance to ensure compliance across the distribution network.

Skills

• Patient-focused mindset with a strong commitment to quality and compliance.
• Collaborative approach with effective cross-functional and external partner engagement.
• Strong ownership and accountability with the ability to drive tasks to completion.
• Analytical thinking and structured problem-solving skills.
• Clear communication and stakeholder management skills in a global environment.

Tools

• Familiarity with temperature monitoring devices and thermal packaging systems.
• Proficiency in quality management systems and documentation practices.