SAP SDG MDM Architect
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.