The Role& Department
As a transport validation manager, you will be working in the CMC – Commercial Supply Chain. Here you will join a Supply chain function of currently 12 members and be reporting to Sr Director Commercial Supply Chain.
With your cold chain experience, you will be responsible for the commercial supply chains in CMC with regards to transport validations. The work will bring you in daily collaboration with our Logistics Team, and you will work closely with several other parts of the organization, including CMC Late-Stage Projects, Regulatory Affairs (RA), and Quality Assurance (QA) our CMO’s as well as Transport providers.
You will be acting as the primary contact in the CMC organization you will drive building up a GxP compliant Transport Validation process and associated documentation framework and be our main driver of ensuring the validation/qualification of transport solutions and shipping routes.
Key responsibilities include
Responsible for Qualification of shipping solutions in close corporation with our internal functions such as CMC Project Managers, Logistics Team, QA, and RA as well as external stakeholders at CMO’s and Logistics Service providers
Responsible for product testing with relevant stakeholders in relation to Transport studies
Drive validation of shipping routes for Intermediates and Finished Goods in our commercial supply chains across EU, US and Japan
Creation and maintenance of supporting SOPs, Work Instructions and Templates for URS, protocols, reports, etc associated with the validation activities
Build and optimize our transport validation processes
Maintain Product Risk Management Plans and drive Lane Risk Assessments and generate shipping validation relevant documentation (URS, protocols, reports, etc)
Support selection and assessment of most optimal transport solutions, lanes and service providers
Work with Quality Assurance in order to maintain GxP compliance throughout the supply chain network including exceptions handling – Investigate exceptions, determine root causes, implement CAPAs and drive closure
Technical or technically oriented degree level, e.g. within engineering, technical operations, logistics or supply chain management
Minimum of 5+ years working experience and experience with process and shipping validation for temperature-sensitive products
Experience within a global and controlled environment
Knowledge of ISTA/ASTM or similar/related standards will be an advantage
This role is located in Copenhagen and is hybrid.
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.
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