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Center Quality Leader - Ireland  

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Posted on : 26 February 2017

Project Description

Role Description
  • Responsible for supporting the execution of the global quality organization strategy. Specifically, developing and review programs focused on ensuring quality, monitoring risk and driving compliance.
  •  The programs developed are aligned to strategy and are applied to global and regional processes.

  • Maintain document control system which includes the review and approval of relevant Standards and Procedures.
  • Support regulatory agency inspections and conduct risk assessment of regulatory agency observations.
  • Responsible for global regulatory and complaint management monitoring.
  • Compile and disseminate Good Manufacturing Process ("GMP") regulatory information, data trending, and knowledge management.
  • Chair key quality indicators council to trend and review key data assessing the overall health of Animal Health's quality system on a twice yearly basis.
  • Assume ownership of Quality Risk Management ("QRM") program with primary responsibility of training sites on QRM use and implementation.
  • Assume ownership of quality systems program with primary responsibility of chairing QSSC.
  • Support sites by assessing quality systems and implementing quality system improvements in Global Supply and for contractors.
  • Support inspection readiness activities at Animal Health global supply sites and provide site inspection behavior training.
  • Assess internal sites and contractors aseptic programs.
  • Benchmark and establish internal standards via quality systems program.
  • Manage aseptic risk assessment tool and support due diligence assessments of aseptic contractors.
  • Assume ownership of company Quality Audits and lead the team of auditors:
  • Define audit frequencies for sites, contractors and suppliers based on risk assessment
  • Oversee audit program with sites and center functions for internal sites, contractors and suppliers.
  • Monitor compliance of the sites, suppliers and contractors, to established quality procedures and guidelines
  • Oversee due diligence assessment process in conjunction with contractors and sites.
  • Oversee audit firms in local markets used to execute Animal Health audits of contractors and suppliers.
  • Monitor adherence of the auditors to the audit standards
  • Ensure that the auditor team is adequately staffed and competent
  • Assume Ownership of LIMs system, maintenance and change management.
  • Lead global aseptic team with site representative driving best practices and implementation of  required aseptic processes SMEs for standards.
  • Responsible for process and templates for Quality Agreements with third parties.
  • Maintain local training system, ensure curriculum is maintained and training completed.

About us:
  • Our company is a global animal health company dedicated to supporting customers and their businesses in ever better ways. 
  • Building on 60 years of experience, we deliver quality medicines and vaccines, complemented by diagnostic products and genetic tests and supported by a range of services. 
  • We are working every day to better understand and address the real-world challenges faced by those who raise and care for animals in ways they find truly relevant.