Job Description

What you will do

Let's do this. Let's change the world. In this lead role you will support the GRC Governance / Policy & Audit team working closely with Technology teams to help ensure that GxP controls are in place, GxP deviations are managed and monitored, and security standards are met. The GxP Specialist will assist in owning and maintaining GxP deviation records, performing GxP assessments, managing controlled documents, and supporting regulatory compliance efforts.

Roles & Responsibilities:

GxP Governance Leadership:

Support the GRC organization in leading a team of GxP and/or policy analysts performing tasks related to governance, GxP deviation management, document management, and 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 ...

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