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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.

Manager, Global Labeling Operations

Primary Lake County, Illinois Secondary Irvine, California Req ID 2211973 Category Quality Assurance Division AbbVie

Manager, Global Labeling Operations

Purpose Statement (2-3 Sentences):

Describe the primary goals, objectives or functions or outputs of this position:

 

Leadership for labeling project management, strategic and tactical label change planning and forecasting of device, device combo, aesthetic, pharmaceutical products 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.

 

 

 

Major Responsibilities:

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

  • Global product leadership for strategic and tactical planning for label change projects
  • Responsibility for the creation, accuracy and completeness of label change projects 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.

 


Qualifications:

List required and preferred qualifications (up to 10). Include education, skills and experience.

  • Bachelor's Degree in Science, Engineering, Business or Supply Chain and minimum of 5 years' experience in Operations, Regulatory or Quality environment
  • Proficiency in English (both written and oral)
  • Experience working effectively across different cultures, multiple functional areas and in complex matrix environments
  • Excellent written and oral communication skills with all levels of management and personnel.
  • Demonstrated success in negotiating and problem-solving skills
  • Strong interpersonal and organizational skills
  • Excellent leadership skills and a proven ability to drive cross functional collaboration.
  • Understands Regulatory, Quality and Supply Chain aspects of labeling and impact of non-compliance
  • Knowledge of applicable regulations and standards affecting Device, Device/Combo, Pharmaceutical or Aesthetic products, specifically regulations and standards affecting the Packaging and Labeling Quality System

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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