IT Compliance Lead needs Technical experience: Mastercontrol, Veeva (eTMF & Quality), Oracle inform, EDC solutions, Argus, SAS, Stability programs, Software as a service (Cloud) solutions and hosted solutions, Trackwise, Sharepoint, Excel, Office 365, Clinplus,
IT Compliance Lead requires:
- data governance
- sarbanes-oxley (sox)
- software quality assurance
- data integrity
- computer validation protocols
- computer validation
IT Compliance Lead duties:
- Author (as needed), review and approve qualification and validation documentation in a timely manner ensuring compliance with SOX, Data integrity, IT security and GxP standards and industry expectations for IT compliance.
- Effectively communicate with other departments within BBI on IT compliance and possible IT validation concerns.
- Ensure any testing errors, deviations from SOP's or IT Compliance observations/non-conformances are properly investigated and explained.
- Actively lead and set tactical guidance on IT Compliance and Computer system validation for BBI IT GxP Projects.
- Support testing execution, including training testers.
- Be the IT Compliance CSV SME for BBI business users and IT teams.