IT Systems ManagerApex Systems is currently hiring for an IT Systems Manager with a reputable pharma client. IT Systems Manager is needed to support an expansion project onsite in Clayton, NC. The ideal candidate will manage multiple systems simultaneously, provide project oversight & drive deliverables, and partner with key stakeholders. This resource will ensure adherence to the client’s & regulatory requirements for assigned IT Systems.
The role will report to the IT/Automation team for the project. The expectation is that tasks will be completed within budget, on time, and within scope.Qualified candidates will have the following experience and skills:Experience with production manufacturing; IT projects & management of IT systems required.Understanding of & knowledgeable in the following areas: IT frameworks such as COBIT, ITIL, GAMP, 21CFR Part 11, &/or PIC/S Annex 11.System development lifecycle including validation of computer systems, operation & maintenance, & decommissioning of systems.Manufacturing processes for manufacturing areas (aseptic, inspection, assembly, packaging, utilities, & laboratories)Expert in GxP documentation practicesExperience in project teams driving deliverables, tasks, & activities for computer system validation required.