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AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

CAPA Manager, IT (Corrective Action/Preventive Action)

Lake County, Illinois Req ID 2205163 Category Information Technology Division AbbVie



Serves as the Business Technology Solutions (BTS) Subject Matter Expert for the CAPA Quality System. Performs and approves root cause investigations for exceptions/nonconformities/deviations to required procedures and/or specifications for IT Systems. Manages GxP audit support activities for the BTS Governance, Risk, and Compliance (GRC) organization.


  • Provides consistent and thorough exception documents and timely resolution of investigations based on
  • CAPA requirements
  • Coordinates the exception document process
  • Promotes culture of continuous improvement by identifying problems, conducting root cause analysis, and confirming appropriate implementation of corrections, corrective and preventive actions
  • Independently leads complex, cross functional, high impact investigations
  • Effectively collaborates/partners with other organizations within Business Technology Solutions (BTS)
  • Manages GxP audit support activities for the BTS Governance, Risk, and Compliance (GRC) organization
  • Establishes KPIs and monitoring processes for both the CAPA and GxP Audit support processes
  • Ensures all Quality CAPA and Audit support goals and metrics are met and communicates relevant data to internal stakeholders
  • Leads team members and/or project teams, including job mentoring or coaching with possibility of direct supervision responsibilities
  • Bachelors degree in a technical field (Biology, Chemistry, Engineering, Computer Science, etc)
  • 7+ years of experience in the pharmaceutical or medical device industries
  • Minimum 2+ years writing and/or approving CAPA documents
  • Minimum 2+ years directly supporting GxP audits
  • Demonstrates ability to problem solve and utilize analytical skills
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: No
Job Type: Experienced
Schedule: Full-time

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