A highly experienced and detail-oriented Quality Assurance Lead is required for an ERP Implementation Project. This role involves leading the quality and compliance aspects of an SAP Cloud ERP transformation. It is a critical position for ensuring GxP compliance, data integrity, and operational excellence across regulated pharmaceutical operations.Location: Onsite in QC Laboratory, Loughrea, Co. Galway.Key ResponsibilitiesDefine and implement the QA strategy for SAP ERP in line with regulatory and operational requirements.Establish and enforce quality governance frameworks, policies, and procedures.Lead the QA workstream within the SAP S/4HANA Cloud ERP programme, following an “Adopt not Adapt” methodology.Collaborate with SAP consultants, business stakeholders, and technical teams to embed quality requirements into system design and configuration.Ensure compliance with GxP regulations, including 21 CFR Part 11 and EU GMP Annex 11.Support the Computer System Validation (CSV) lead and coordinate with external vendors.Review and approve project documentation.Implement audit trails, electronic signatures, and access controls to guarantee inspection readiness and data integrity.Act as the main liaison between stakeholders and project teams on all quality-related matters.Facilitate workshops and training sessions to strengthen compliance culture.Monitor quality KPIs and drive continuous improvement initiatives.Provide quality insights to manufacturing, supply chain, and regulatory teams to optimise operations.Skills & CompetenciesIn-depth knowledge of SAP S/4HANA or SAP Cloud ERP in regulated pharma or CDMO environments.Practical experience with:Quality Management (QM) moduleBatch management and traceabilityInspection planning and executionIntegration with LIMS and EQMSFamiliarity with SAP Best Practices and Fit-to-Standard methodology.Strong understanding of GDP, GxP, 21 CFR Part 11, EU GMP Annex 11, and ALCOA++.Experience supporting CSV activities and audit readiness.Proven leadership of QA workstreams in large-scale ERP implementations.Proficiency with SAP Signavio or similar tools for process modelling and validation traceability.Strong leadership, communication, and stakeholder management skills.Qualifications & Experience5+ years of Quality Assurance experience in regulated pharmaceutical or CDMO environments.Extensive ERP implementation experience with a strong focus on SAP systems.Demonstrated leadership in CSV and QA-driven ERP projects.Familiarity with tools such as SAP Signavio for process modelling and validation traceability.Experience with AI/ML tools for quality monitoring and validation (desirable).
