Description
As a member of IT Quality, the IT Compliance Manager helps to define, plan, and perform duties that support management of key IT Quality related processes including implementation of the IT Controls framework, IT Quality Risk Management, and serving as a key partner to IT management regarding ITQ related initiatives and goals.Responsibilities
- Must have proven experience in Part 11 compliance from a Quality prospective
- Act as QA Project Lead for all IT programs from begin to completion
- Conduct in-depth review of IT Change Control and computerized Risk Assessment processes and documentation
- Participate as an audit team member for vendor/suppliers providing computerized support and/or services
- Participate in the creation of computer system design and implementation documents from a Quality view point to ensure Part 11 compliance
- Drive execution of Risk Management activities and deliverables, including Risk Management plans, assessments and reports
- Partner with IT management (Business Information Managers, Global Application Management and Infrastructure) to plan and implement business continuity roadmaps
- Ensure implementation activities identified for each of the IT Controls processes are executed per defined schedules
- Liaison with Quality partners (PO&T and R&D) to ensure IT inspection preparation activities are completed per inspection and audit schedules
Qualifications
- 8-10 years' experience in Quality with a focus on IT Hardware & Software Implementation
- Experience with Livelink, ComplianceWire, ARISg, ComVault, SAS, VM-Ware and Sharepoint a plus
- Strong IT technical background
- Experience authoring SOP's related to IT Change Control & processing
- Strong knowledge of cGMP, GCP and ICH guidelines, Part 11 for US, Canada and EU market
To find out more about Real please visit www.realstaffing.com