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About AbbVie

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.

Senior IT Compliance Consultant

Chicago, Illinois Req ID 2207177 Category Information Technology Division AbbVie

Purpose

Supports GxP regulatory inspections and quality audits, provides guidance and manages GxP audit request evidence using a single point of contact (SPOC) GxP audit request process. Responsible for the interpretation and communication of GxP systems compliance regulations and ensures documentation follows policy and procedures.

Partner with peers, stakeholders, and business, provides senior-level consultation and direction to functional areas for GxP system compliance policy, process, and procedures.

Identifies, proposes, initiates, and leads significant improvement programs related to IT Compliance policy, processes, and procedures.

Lead and drive compliance activities across multiple projects or stakeholder areas. Performs resource planning and allocation across multiple areas for IT Compliance activities.

Responsibilities

  • Lead harmonization of GxP audit request process, minimizing impact to stakeholders. Drive SPOC audit request process using central audit supporting tool.
  • Monitor and ensure timely, complete, and accurate fulfillment of all audit requests, regardless of time zone.  Provide daily oversight to Managed Service Provider’s fulfillment of audit requests, providing feedback and driving to Right First Time
  • Implement additional self-service tools for stakeholders; document lessons learned and address/resolve any actions identified.
  • Develop and publish metrics, focused on identifying improvement opportunities to reduce compliance risk
  • Proactively identify compliance improvement opportunities. Drive process improvements, identifying opportunities to simplify and streamline solutions while ensuring organization remains compliant.
  • Implement and lead mock audits/assessments for GxP systems, leveraging learnings to influence improvements across teams
  • Drive alignment for GxP compliance with applicable Corporate and Global policies and procedures.
  • Provide guidance during review and approval of IT system documentation.
  • Build and sustain relationships with system stakeholders, business stakeholders, and teams responsible for providing audit support, including Managed Service Provider resources.

 

Qualifications:

Qualification

•Bachelor's Degree with 7 years’ experience; Master's Degree with 6 years’ experience

•Experience in a quality systems environment, preferably manufacturing/quality experience.

•Excellent analytical, judgment and consultative capabilities and communication skills and the ability to work with IT management and staff.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 5 % of the Time
Job Type: Experienced
Schedule: Full-time
ABBVIE

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