Beschreibung
Tasks & Responsibilities-Leads the system support (master data management, process support, testing, validation, documentation and training) regionally for the efficient, effective operations of CellChain and for all internal and external stakeholders.
-Lead the CellChain support for user management, master data management and change control.
-Build user adoption and expertise in utilizing CellChain to enhance customer engagement and supply chain performance.
-Develop and implement CellChain continuous improvement opportunities.
-Manage country launches including corresponding site set-ups and user account set-ups in support of all commercial and clinical launches.
-Implement the medium and long term operational strategy for CellChain with a focus on: o Scaling the business – Customer engagement, New Clinical Trials, -Commercial PedALL, DLBCL, Country Launches, New Treatment Sites, New Manufacturing Sites. o Enhancing supply chain performance
-Maintaining COI o Tighter integration and engagement with CellChain business partners (Treating Sites, Aph Centers, Cell Labs, Service Providers) o Streamlining and maintaining Computer System Validation o Mobile platform strategy
-Support CellChain system releases managing PQ testing, change control impacts, user training.
-Improve the System Evolution and Lifecycle processes for CellChain
Must Haves
-University Degree in supply chain management or operations.
-The following certifications a plus: APICS CSCP, CPIM English
-Deep supply chain system experience with ERP and CRM applications.
-Deep experience with GxP Validated systems.
-International experience a plus.
-Significant project management experience, particularly with running complex multi-functional technology projects that tie technology solutions to business operations and internal and external stakeholders.
-Program Management experience a plus.
-Experience in supporting tools (Microsoft Project).
-ERP Master Data set-up subject matter expert
-Experience in a cGMP manufacturing environment. Deep experience in supporting 21CFR Part 11 Computer System Validation and HIPAA regulations.
-Broad general business knowledge with experience collaborating with and supporting multiple functional areas, such as commercial, finance, quality, regulatory, compliance, IT and manufacturing.
-FDA Audit participation experience.