Tasks and Responsibilities:
• 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:
o Scaling the business – Customer engagement, New Clinical Trials, Commercial PedALL, DLBCL, Country Launches, New Treatment Sites, New Manufacturing Sites.
o Maintaining COI
o Maintaining Computer System Validation
• Support CellChain system releases performing PQ testing, change control impacts, user training and procedure updating.
• Supply chain system experience with SAP ERP and SFDC CRM applications. Experience with GxP Validated systems. International experience a plus.
• Experience in a GMP 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.
If you are available immediately and meet the requirements above, please apply today!