Looking for a new opportunity? Apply today to hear about our exciting new role with a large and growing pharmaceutical company in Dublin!
Purpose:
Leadership for labeling 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 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.
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 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 business process 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:
· 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 labeling 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 Labeling Quality System
· Strong project management skills including stakeholder management,