Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
We are currently looking for a Global Labelling Operations Manager to join our team in Dublin. This role provides leadership for labelling project management, strategic and tactical label change planning and forecasting of label changes to ensure the Global Label Management organisation 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 with content and market requirements for new product launches, safety updates and other core labelling programs.
- 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 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 a 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 organisational 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.
- Hybrid working model (3 days in our office in Dublin)
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
