Perform 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.
* Perform 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.
* Participate in country launches including corresponding site set-ups and user account set-ups in support of all commercial and clinical launches.
* Engage in the short and medium term operational strategy for CellChain with a focus on:
* Scaling the business - Customer engagement, New Clinical Trials, Commercial PedALL, DLBCL, Country Launches, New Treatment Sites, New Manufacturing Sites.
* Maintaining COI
* Maintaining Computer System Validation
* Support CellChain system releases performing PQ testing, change control impacts, user training and procedure updating.
Key Performance Indicator(s)
* Implements technology solutions that drive performance in the following Supply Chain KPI's:
* Application performance: Application availability, Robust Validation Strategy Data Accuracy: Master Data set-up, user account set-up, Data associations Resource utilization: Timeliness and quality of new treatment site and manufacturing site set-ups
* Quality: data setup first-time-right
* Front Line Support: User engagement, user satisfaction, escalation as needed HSE (Occupational Accident Rate)
* University Degree in supply chain management or operations. The following certifications a plus: APICS CSCP, CPIM English
* Supply chain system experience with SAP ERP and SFDC CRM applications. Experience with GxP Validated systems. International experience a plus.
* Experience in a cGMP manufacturing environment. 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
Cognizant is a provider of information technology, consulting, and business process outsourcing services.