IT Compliance Lead in Cambridge, MA

$160K - $170K(Ladders Estimates)


Cambridge, MA 02138

Industry: Pharmaceuticals & Biotech


Not Specified years

Posted 56 days ago

  by    Ella Francis Lee

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)
  • SOP
  • SAAS
  • 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.

Valid Through: 2019-9-17

$160K - $170K