Global Labeling Operations Manager

hace 2 semanas

Bogotá, Bogotá D.E., Colombia ABBVIE A tiempo completo
We are looking for a

Global Labeling Opearations Manager:

In this position you will be the leader for labeling project management, strategic planning and forecasting of label changes 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, among others, to achieve the Perfect Label.

Ensures assurance of supply and compliance to content and market requirements for new product launches, safety updates and other core labeling programs.


Main responsabilities:

  • Responsible for implementing and maintaining the effectiveness of the quality system by delivering the "perfect label" to our customers through an effective and efficient label change management process. The Perfect Label is defined as compliant with content requirements and timely implementation, both internal and external to AbbVie.
  • Collaborate with key stakeholders to create and execute label change strategy for key label change projects, and labeling changes for early development, submission and production artwork to prioritize deliverables.
  • Comply with the labeling change schedule to meet established timelines. Communicate and negotiate exceptions to planned delivery dates.
  • Lead role to represent Label Center in early development labeling work including functioning as lead Label Change Coordinator for labeling launch activity.
  • Identify continuous improvement ideas to improve right first time and schedule conformance.
  • Evaluate the impact of a label change on associated labels and manufacturing operations.
  • Ensure completeness, accuracy, and control of changes in labeling including maintenance of labeling related specifications and documentation associated with these specifications.
  • Work closely with Graphics in the creation of label artwork, mock ups utilized for regulatory submissions, and assist commercial, as required, in the development of label designs for packaging and labeling commodities.
  • Work closely with Proofreading for the verification of developed label copy against the source documents.

Requirements:

  • Years of experience: 6+ years combined experience from totals: Quality/Regulatory, Operations, Pharmaceutical/Device Regulations.
  • Bachelor's Degree in Business / Engineering/Sciences preferred. Equivalent successful industry experience.
  • Individual must have a breadth of experience to establish and maintain credibility across functions, with stakeholders and with senior management.
  • Ability to motivate and influence others over whom they have no direct authority.
  • Knowledge of applicable regulations and standards affecting Pharmaceutical, Device, Device/Combo Products, specifically regulations and standards affecting the Packaging and Labeling Quality System.
  • Ability to logically reason, solve problems, and make decisions on key issues independently.
  • Selfmotivated and strong focus on details and accuracy.
  • Strong written and interpersonal communication skills.

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