Overview
Global Labelling Operations Manager – Dublin, Ireland (Hybrid)
NIRAS Ireland specializes in design and delivery of process-driven and high end life science projects. We provide Project Management, Engineering Design, Project and Managed Service resources to the advanced Process Manufacturing, Life Science, Food & Beverage sectors across Ireland and internationally.
NIRAS Ireland are currently recruiting a Global Labelling Operations Manager at our client's advanced pharmaceutical manufacturing facility based in North Dublin. This is a 12 month contract with the selected candidate joining a team of other managers, reporting to the section manager for Global Labelling Operations, collaborating with colleagues in global sister sites but responsible for own products and countries.
Role
Leadership for labelling project management, strategic and tactical label change planning and forecasting of label changes to ensure Global Label Management organization meets its performance objectives. The position will lead packaging and artwork strategy and shared label strategy across 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 Brief phase within Artwork Management System to ensure compliance with regulatory requirements
* Act as business process owner for specific Labelling business processes and assume role of documentation SME
* Project Management responsibility within 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 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
* Lead role to represent GLM in early development Labelling work incl. functioning as lead for Labelling launch.
Qualifications
* Knowledge of applicable regulations and standards affecting Pharmaceutical, Device, Device/Combo Products, specifically regulations and standards affecting the Packaging and Labelling Quality System
* 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 across different cultures, multiple functional areas and in complex matrix environments
* Strong interpersonal and organizational skills
* Excellent written and oral communication skills with all levels of management and personnel.
* Demonstrated success in negotiating and problem solving 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
What to Do Next
For a confidential discussion regarding this and our many other exciting opportunities with NIRAS Ireland, please contact Philip Cahill at 00353 482 2270 /00353 87 997 9941 or email your cv to phic@niras.com
About NIRAS
One of Europe's largest development consulting firms. NIRAS employs over 3000 permanent staff and has a pool of 25,000+ experts across our network. With 51 offices in 32 countries. A value-driven, multi-disciplinary engineering consultancy, NIRAS is fundamentally committed to sustainable progress and service delivery. At NIRAS you can grow! Come join us.
Seniority level
* Mid-Senior level
Employment type
* Contract
Job function
* Supply Chain and Quality Assurance
Industries
* Pharmaceutical Manufacturing and Medical Equipment Manufacturing
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