Manager, Label Change Coordination

Global Label Management (GLM) in Operations Quality is responsible to deliver the Perfect Label; assuring timely implementation and accurate content. GLM operates as a global integrated organization and facilitates the end-to-end labeling implementation process. Making the perfect label possible every time.

The Manager in GLM's Label Centers facilitates the execution of label changes for the AbbVie products assigned to his or her team. Operating in a global and cross-functional environment, the Manager provides leadership to ensure that quality of the labeling meets the highest AbbVie and industry standards.

Responsibilities

• Foster an environment where everyone drives a compliant, efficient and effective end to end labeling process, striving for a 100% right first-time rate and schedule conformance
• Manage a team of label change coordinators
• Enable the perfect label in alignment with QPP16 procedures and according to schedule and Right the First-Time principles
• Manage all exceptions and priorities within the execution of the milestone level plan and communicate potential issues to stakeholders.
• Consult with regulatory & affiliates for alignment of artwork.
• Develops and maintains GLM performance metrics monitoring programs, reports performance metrics on a periodic basis and translates resulting corrective/preventive action plans into proposals for continuous improvement projects to continuously raise the bar for global performance.
• Anticipates and communicates potential discrepancies between available capacity and forecasted capacity needs within the Global Label Center and provide proposal for possible solution to close the gap.
• Ensure effective planning of resources and management of day-to-day labeling activities.
• Participates or assigns team resources in support of local and global end-to-end labeling projects as well as drives/influences alignment towards project execution strategy.
• Provides guidance on impact of business process improvements on AbbVie policies and procedures.
• Partners with Area Labeling and Product Labeling on forecasted labeling projects and process improvements.
• Drive a culture of innovation, continuous improvement and global standardization within the label change management process.
• Manage label error exception reporting, investigations, corrections, corrective actions and preventive actions.
• Partner with internal and external auditory bodies to ensure all inspection activities are supported in a professional and efficient manner.
• Monitors labeling activities to ensure artwork is timely available for submission and production.
• Assign product, plant, procedure and project SME's and act as business process owner for assigned processes.
• Develop and implement the staffing model for labeling team, including hiring, performance, training, coaching and goal setting.
• Support growth and development of team members through leading by example, identifying strengths and weaknesses and applying the AbbVie talent management philo sophy.

• Bachelor's Degree in Business / Engineering/Sciences preferred. Equivalent successful industry experience (minimum 6 years) can be considered
• Preferred: Labeling experience in Pharmaceutical or Biotech industry. Minimum of 6 - 8 years combined experience from the following areas: Quality/Regulatory, Operations, Pharmaceutical/Device Regulations.
• Fluency in English.
• Results driven.
• Successful implementation of projects and continuous improvement activities.
• High affinity to IT systems.
• 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.
• Self-motivated and strong focus on details and accuracy.
• Strong written and interpersonal communication skills.