Senior QA Specialist - Supplier Quality

HRM Search Partners; Limerick; On-site; EUR 80,000 - 110,000; Full time

Job summary

HRM Search Partners is seeking a Senior QA Specialist - Supplier Quality for our client, a global pharmaceutical organisation in Limerick. The role provides quality oversight across suppliers and service providers to ensure GMP compliance and alignment with site requirements.

You will lead supplier qualification, risk assessment, quality agreements, and performance monitoring, collaborating with Quality, Procurement and Technical Services to drive continuous improvement in a next-generation

Qualifications

• Minimum six years' QA experience in a regulated pharma environment.
• Level 7 qualification or higher in Science or Engineering.
• Strong knowledge of cGMP and regulatory expectations (FDA/EMA/HPRA).
• Experience with supplier quality activities, qualifications and performance oversight.
• Experience with deviations, change controls and CAPAs.
• Excellent communication and stakeholder management skills.
• Experience with TrackWise or similar QA systems is advantageous.

Responsibilities

• Provide quality oversight of suppliers to ensure GMP compliance.
• Maintain relationships with suppliers and support SRM activities.
• Manage supplier qualifications, questionnaires, quality agreements, and re-evaluations.
• Review change notifications, deviations, and change controls with CAPAs.
• Conduct risk assessments in collaboration with Procurement and Technical Services.
• Monitor supplier quality performance and drive continuous improvement.
• Support material approval for production and process validation activities.
• Apply regulatory guidance across Quality Systems and supplier-management programs.

Skills

Quality Assurance

Supplier Quality

Stakeholder Management

Analytical skills

Communication

Problem solving

cGMP knowledge

Education

Level 7 qualification in Science/Engineering

Tools

TrackWise

DCS

DeltaV

Job description

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.

Responsibilities

• 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.

Experience

• 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.