Senior Specialist, Transport Validations

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

• Lead qualification of shipping solutions and transportation equipment (e.g., thermal shippers, containers, temperature monitoring devices) in collaboration with CMC, Logistics, QA, and RA
• Drive validation of shipping lanes for intermediates and finished goods across Genmab's global commercial network
• Ensure transportation solutions meet defined product requirements and regulatory standards

• Plan and execute qualification activities for transportation equipment, including thermal packaging systems and monitoring devices
• Ensure equipment performance is robust and documented in accordance with GxP expectations

• Develop, maintain, and continuously improve SOPs and related documents governing transportation validation and distribution activities
• Standardize and optimize validation processes to ensure scalability, efficiency, and compliance
• Ensure alignment with Genmab's Quality Management System

• Maintain Product Risk Management Plans related to distribution.
• Lead Lane Risk Assessments to proactively identify and mitigate supply chain risks
• Author, review, and approve validation documentation (e.g., URS, protocols, reports) in line with internal and regulatory requirements

• Support selection, qualification, and performance evaluation of transport solutions, lanes, and logistics service providers
• Collaborate closely with CMOs and external logistics partners to ensure compliant and effective distribution solutions

• Partner with QA to ensure GxP compliance across the distribution network
• Lead investigations of deviations and transport-related exceptions, including root cause analysis and CAPA implementation
• Drive timely closure of quality events and ensure continuous improvement

• Bachelor's or Master's degree in Life Sciences, Engineering, Supply Chain, or related field
• Solid over 5 years 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 CMOs and logistics service providers in a global setup

• Patient-focused mindset with strong commitment to quality and compliance
• Collaborative approach, able to work effectively across functions and with external partners
• Ownership & accountability, with the ability to drive tasks independently to completion
• Analytical thinking and structured problem-solving skills
• Clear communication and stakeholder management skills in a global environment

• You are genuinely passionate about our purpose
• You bring precision and excellence to all that you do
• You believe in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
• You take pride in enabling the best work of others on the team
• You can grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so!