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Site Quality Lead

Location: Dublin, Republic of Ireland
Salary: Negotiable
Posted: 8 months ago
Role type: Permanent
Industry: Science Leaders & Specialists
Contact name: Shane Browne
Contact email: shane.browne@hrmrecruit.com

Job description

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.

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Shane Browne

Director - Life Sciences & Engineering Technology Practice

Current assignments