Job Description
The IT Business Systems Manager will serve as the IT System Owner for the quality learning management system (LMS), quality management system (QMS), and electronic document management system (eDMS). This position requires partnering with the Quality team to ensure that ComplianceWire and Vault Quality solutions meet the needs of the cross-functional GxP business community.
Deep understanding of Veeva Vault Quality, specifically QMS Quality Event and QualityDocs applications, is essential. Experience in a hybrid waterfall-iterative methodology is expected, involving an incremental approach to gather and refine scope with solution options before executing a controlled deployment. The individual will oversee IT support, prioritize activities, and review business systems and user needs. They will also coordinate support activities across vendors, troubleshoot technical issues, and represent IT in Computer System Validation (CSV) activities. This role will facilitate IT Computer System Validation activities, including implementation, system release management, and support. Documentation may include System Impact Assessments, Plans, Requirements/Specifications, Test Scripts, Data Migration, Traceability Matrix, and Summary Reports.
About Apellis
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies.