AbbVie Global Operations Quality Strategy Leader in Dublin, Ireland
AbbVie employees work every day to discover and address many of the world's most pressing health challenges. Our work helps people live better lives. When you have patients depending on your solutions, you look for the best people to be part of the team. We are always looking for talented people to join our team and, when we find them, we make it our business to treat them well. Choose AbbVie if you share our passion for improving the health and lives of patients.
We are currently sourcing a Global Operations Quality Strategy Leader to join our Global Quality team in Santry, Dublin. This role supports the API and Drug Product operations across Europe (Ireland, Germany and Italy).
As part of AbbVie’s enterprise quality strategy, this role directs the implementation and maintenance of consistent standards for unit operations production processes and controls across all manufacturing sites. In partnership with Global Quality Centers of Excellence, evaluate recommended processes, policies and procedures making recommendations to update and align resulting in standards that accurately drive expected patient and business outcomes. Together with Leaders of Quality and Manufacturing worldwide, ensure that operations controls are put in place and effectively leveraged to achieve process and practice simplification, operational efficiencies and performance excellence. Develops and maintains relationships internally and externally to ensure global product quality standards are fully achieved and continuously evolve to stay aligned with regulations and requirements.
Key Responsibilities Include:
- Create strategic road-maps to drive improvements in Operational Quality performance to enhance quality metrics, RFT rate and inspectional performance.
- Translate strategic roadmaps into the Quality LRP, gaining inputs and agreement from global stakeholders and ensuring targets are scientifically based and achievable.
- Establish and manage Global Quality programs to ensure that the Quality LRP targets are delivered.
- Lead implementation and optimization of the "Pharma 3" Global Quality System business processes and practices. Evaluate recommendations, align enterprise standards and metrics, and guide effective application within sites. Ensure historical business process and practices are stopped and replaced by new expectations; lead updating roles and responsibilities of team members as necessary to support optimized business processes.
- Lead manufacturing review and coordination of Unit Operations policies/procedures and practices. Secure Global approvals on actions related to Unit Operations and lead the global delivery of standardized efficient Unit Operations. Transition of the business to newly established processes and practices.
- Ensure accurate KPIs are developed and monitored routinely for new Quality Systems business processes developed and deployed; analyze issues and performance across the network, anticipate issues and recommend actions to address problems proactively (for example, on recurring / high impact NCRs and LIRs). Secure approvals on actions related to unit operations and lead implementation.
- Develop and effectively manage key relationships with business partners, in particular Operations and Commercial Supply chain leaders.
- Interface routinely with Global Quality Leaders, Regional Leaders in Quality and Manufacturing, as well as cross-functional AbbVie leaders in matters related to manufacturing quality. Actively partner with Site Leaders to monitor, assess, and improve practices that ensure product quality meets all regulatory and patient standards.
- Bachelor’s Degree required; preferably in Physical or Life Sciences, Pharmacy, or Engineering. Masters/PhD. preferred.
- Certified Quality Engineer or formal training in quality engineering or statistics is preferred.
- Qualified Professional (QP) is strongly preferred for plants in Europe.
- 12 years of combined experience Experience in Manufacturing, QA, R&D in pharmaceutical, biologics, device or chemical industry – 10 years Quality or Manufacturing large group supervision - 6 years Quality Management experience - 5 years.
- Must have a basic understanding and working knowledge of the physical and chemical characteristics of the products, including raw materials, manufactured at the plant.
Job Classification: Experienced
Job: MANUFACTURING & OPERATIONS
Primary Location: Ireland-Leinster-Dublin
Travel: Yes, 20 % of the Time
Req ID: 1704069