As a Change Control Specialist, you'll be part of the global Manufacturing, Science, and Technology (MSAT) organization. Your primary objective will be to support and drive change management initiatives for global platforms. This involves initiating and managing new change controls, focusing on the transfer of CAR-T technology and process improvements.
You will be responsible for:
Facilitating engagement among cross-functional stakeholders to ensure changes are implemented smoothly.
Clearly defining business cases and justifications for change.
Daily use of a Quality Management System (QMS) to support operational activities.
Collaborating with various sites in both the EU and the US to support process improvements and technology transfer.
Creating and maintaining technical documentation.
Networking with external contract manufacturing organizations (CMOs) and internal stakeholders to ensure seamless process execution.