Automation/ QA Engineer

Manager, Global Labelling Operations

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.

Purpose of this position is to provide leadership for labeling project management, strategic and tactical label change planning and forecasting to ensure the Global Label Management organization meets its performance objectives. The position will lead packaging and artwork strategy and shared label strategy across the product lifecycle. Responsibility to lead cross functional teams and drive alignment for labeling projects including manufacturing, engineering, regulatory and supply chain to achieve the Perfect Label. Ensures assurance of supply and compliance to content for new product launches, safety updates and other core labeling programs.

This role is responsible for the labeling change management of AbbVie’s marketed products in compliance with Ministries of Health, Regulatory, and production facility requirements.

  • Global product leadership for strategic and tactical planning for label change projects.
  • Responsibility for accuracy and completeness of the Brief phase within the Artwork Management System.
  • Project Management responsibility within the system for Production, Design and Asset workflows.
  • Lead label change projects and associated deliverables for launches, site transfers, country/area specific changes and other labeling focused projects.
  • Lead the periodic formal review process for label change management and develop and report performance metrics within label change execution.
  • Ownership and leadership role within the Packaging and Artwork Strategy.
  • Lead shared label strategy development and maintenance over the product life cycle.
  • Change Plan ownership for labeling operations.
  • Act as owner for specific labeling business processes and assume role of documentation subject matter expert.
  • Lead role to represent GLM in early development labeling work including functioning as lead for labeling launch activity.