A leading global Pharmaceutical company dedicated to supporting customers and their businesses in ever better ways. This organisation delivers quality medicines and vaccines, complemented by diagnostic products, genetic tests, biodevices and a range of services. Selling into over 100+ countries with with over 10,000 employees, this organisation is one of the largest healthcare organisations in its defined sector. Expanding heavily here in Ireland with the acquisition of a number of manufacturing sites, this organisation has a new requirement for a Site Quality Lead to head up its sterile manufacturing plant in Dublin.

The Position:

• Establishing / Reinforcing the Quality Culture on the Site; Contributing member of the Site Leadership Team
• Implementation of Quality Standards
• Maintain Site Inspection Readiness. Promote Compliance Audit findings/remediation
• Insure that products are manufactured in compliance with Registration File (and appropriate Reg Bodies)
• Insure Product Release is done within Regulatory Standards and pertinent Registration Files
• Insuring QC Testing meets Regulatory Compliance and GMPs
• Proactive Ownership of the Site Risk Assessment process
• Oversee the development and implementation of the Quality Plan / Quality Road Map
• Share Leadership of Site Quality Councils and Metrics
• Develop metrics to deliver product and process improvement
• Maintain the Supplier Quality program and vendor certification
• Insure the Validation Master Plan is compliant and up to date. (Validation strategy and site compliance)
• Create and be accountable for the Site QA/QC Budget
• Champion Leadership Development for the Site Quality Staff
• Overall Site Product Portfolio Quality Stewardship owner and accountability

The Person:

• Science or Engineering BS / MS / PhD
• Demonstrated significant leadership experience in a Quality Role in Animal Health / Human Health manufacturing
• Operations or Quality Experience in Biological and/or Aseptic Manufacturing (adjust as applicable)
• FDA, USDA, and EU regulated work experiences desired (adjust as applicable)
• Fluent with Six Sigma and/or Lean Manufacturing

To learn more about this role apply online or contact Shane Browne on + 353 1 6321865 for a confidential discussion.