Labelling Manager

4 weeks ago

Dublin, Dublin City, Ireland Arcadis Full time
Overview

Arcadis are seeking a Global Labelling Operations Manager for a Pharmaceutical company in Dublin on a 12-month rolling contract basis

Purpose:

Leadership for labelling project management, strategic and tactical label change 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 labelling 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 labelling programs.

Responsibilities
  • Global product leadership for strategic planning and forecasting of label change projects
  • Responsibility for accuracy and completeness of the Brief phase within the Artwork Management System and to ensure compliance with regulatory requirements
  • 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 labelling 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 labelling operations
  • Act as business process owner for specific labelling business processes and assume role of documentation subject matter expert
  • Lead role to represent GLM in early development labelling work including functioning as lead for labelling launch activity.
Qualifications
  • 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.
  • Understanding of Regulatory, Quality and Supply Chain aspects of labelling and impact of non-compliance
  • Knowledge of applicable regulations and standards affecting Pharmaceutical, Device, Device/Combo Products, specifically regulations and standards affecting the Packaging and Labelling Quality System
  • Strong project management skills including stakeholder management

Interested parties should forward a copy of their CV marked for the attention of Fergal Walshe or contact me via LinkedIn for more information on the role.


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