Job Description

Roles & Responsibilities:GxP Governance Leadership

  • Support the GRC organization in leading a team of GxP and/or policy analysts performing tasks related to information security governance, GxP deviation management, document management, audit commitments, and/or policy exception processes.

GxP Deviation and CAPA Management:

  • Manage and own technology related GxP deviations, CAPA, and CAPA-EV records
  • Manage GxP reporting and monitoring metrics for Technology/IT records
  • Collaborate with record owners and QA to ensure timely record resolution
  • Lead the identification and evaluation of risks associated with GxP deviation records.
  • Identify and support new record owners across IT/Technology (e.g. office hours, ad-hoc meetings, document management support).
  • Attend enterprise network meetings and Quality Forums as needed to represent the Technology / IT function .
  • GxP Dev...

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