Owns change control management within CGTDM-ESM group. This includes process, analytical and logistical changes that need to be implemented at various CMO’s. Manages and executes change requests by respective IT tool in collaboration with members of various supplier relationship teams. Assures smooth change control process with different stake and action holders in order to ensure timely supplies. Acts as main ESM contact person and coordinator for changes originating at central NTO-CGTDM manufacturing site to assure aligned rollout to various CMO’s. The Change Control Manager also acts as project lead of global cross-functional teams to define strategy for major changes and to ensure respective implementation.
• To lead cross-functional evaluation and implementation phases of change requests, considering the most effective implementation strategy, priorities, cGMP’s, regulatory requirements, Novartis Pharma Corporate Quality Manual, Novartis policies and cost effectiveness.
• Acts as Change Phase Manager, Change Initiator and Change Action Holder in the respective Change Control IT tool.
• Organizes and support document management of CMO documents impacted by changes, incl. respective documentation updating in Novartis repository.
• In collaboration with members of Supplier Relationship Team(s) ensures timely implementation of change actions. Follow up with action holders not delivering on time.
• Acts as main ESM contact person and coordinator for changes originating at central NTO-CGTDM manufacturing site to assure aligned rollout to various CMO’s.
• As applicable the Change Control Manager also acts as project lead of global cross-functional teams to define strategy for major changes and to ensure respective implementation. Drives the definition of project milestones for projects managed by the CCM and ensures project implementation is done according to the agreed timelines.
• To support other ESM members in evaluation, planning and execution for main and sub change actions.
• To ensure efficient, timely and clear communication to all involved partners (internal and at CMO’s) as required for flawless change or project execution.
• To communicate change/project progress and deviations as appropriate. To elaborate risk mitigation plans as appropriate.
• To ensure timely delivery of complete and consistent source data to DRA RegCMC.
• To solicit input from relevant Novartis functions and to ensure that CMO specific information is made available in global projects and in relevant databases.
• Define and establish the master data strategy and tasks together with ESM-SOM, SC and SRM.
• Training: Ensures and supports adequate training of other ESM members on change control managements tasks.
• Audit support: Maintain work in inspection readiness level on change control matters and to provide the necessary support in any internal or external audit.
Change Control Manager Cell and Gene Therapy Unit