Senior QA Specialist - Supplier Quality

Our client is a global pharmaceutical organisation seeking a Senior QA Specialist - Supplier Quality to join its Limerick manufacturing facility. The successful candidate will provide Quality oversight across suppliers and service providers, ensuring materials and services meet GMP, regulatory and site requirements. The role will support supplier qualification, relationship management, quality agreements, risk assessment and ongoing supplier performance within a next-generation manufacturing environment.

• Provide Quality oversight of suppliers and service providers, ensuring compliance with GMP requirements, internal policies, procedures and quality-system standards.
• Build and maintain effective relationships with suppliers and service providers, supporting Supplier Relationship Management activities for strategic and critical partners.
• Manage supplier and service-provider qualification activities, including questionnaires, evaluation packages, quality agreements and ongoing re-evaluation.
• Review and approve supplier change notifications, deviations and change controls, ensuring appropriate CAPAs and implementation actions are completed.
• Conduct Quality risk assessments in collaboration with Procurement and Technical Services, including assessment of risks throughout the supply chain.
• Monitor supplier and service-provider quality performance, identify emerging issues and contribute to problem analysis, corrective actions and continuous improvement.
• Support material approval for production and process validation activities and maintain approved supplier, service-provider and manufacturer information within relevant systems.
• Interpret emerging regulatory and GMP guidance and support its application across relevant Quality Systems and supplier-management programmes.

• Minimum six years' relevant experience within Quality Assurance, pharmaceutical, biopharmaceutical or another highly regulated manufacturing environment.
• Level 7 qualification or higher in Science, Engineering or a related discipline.
• Strong knowledge of cGMP requirements and relevant regulatory expectations, including FDA, HPRA, EMA, Data Integrity and Quality Risk Management.
• Experience supporting supplier or service-provider quality activities, including qualification, risk assessment, quality agreements and performance oversight.
• Experience managing or providing Quality input to deviations, change controls, CAPAs and supplier change notifications.
• Strong analytical and problem-solving capability, with the ability to assess quality risks and develop evidence-based solutions.
• Effective communication and stakeholder-management skills, with the ability to work cross-functionally and manage relationships with external suppliers and service providers.
• Experience with quality-management systems such as TrackWise and automation platforms including DCS or DeltaV would be advantageous.
• Opportunity to join a next-generation biopharmaceutical manufacturing facility within a global pharmaceutical organisation.
• Broad exposure to supplier quality, quality systems, risk management and GMP compliance across strategic suppliers and service providers.
• Work closely with Quality, Procurement, Technical Services and external partners on critical supplier and supply-chain activities.
• Opportunity to contribute directly to supplier performance, continuous improvement and the ongoing quality and reliability of manufacturing operations.