Center Quality Leader - Ireland
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- 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.
- 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.