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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 www.abbvie.com. 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

 

Purpose:

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.

Responsibilities:

  • 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
Qualifications:
  • 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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