QA Lead

1 week ago

Limerick, Ireland Team Horizon Full time

Team Horizon is seeking a Quality Lead who will oversee the quality and compliance aspects of a SAP Cloud ERP transformation. This is a critical position to ensure GxP compliance, data integrity, and operational excellence across developing and growing pharmaceutical operations. Why you should apply: - Work with an Industry Leader with Global Reach, exporting to over 90 countries and holding thousands of product licenses in both human and animal health. - Career Growth & Development, benefit from strong investment in employee training and professional development, with opportunities to grow within a rapidly expanding and internationally recognized business. - Modern Facilities & Regulatory Excellence, Gain experience in FDA-approved, high-standard manufacturing and R&D environments, supporting innovation and quality in pharmaceutical production. What you will be doing: - Defining and implementing the QA strategy for SAP ERP aligned with regulatory and operational requirements. - Establishing and enforcing quality governance frameworks, policies, and procedures across all relevant domains. - Leading the QA workstream within the SAP S/4HANA Cloud ERP programme, aligned to an "Adopt not Adapt" methodology. - Collaborating with SAP consultants, business stakeholders, and technical teams to ensure quality requirements are embedded in system design and configuration. - Ensuring the ERP system complies with GxP regulations, including 21 CFR Part 11 and EU GMP Annex 11. - Supporting and working with the Computer System Validation (CSV) lead and supporting vendors regarding related processes and activities. - Ensuring documents are reviewed and approved appropriately. - Implementing audit trails, electronic signatures, and access controls to support inspection readiness and data integrity. - Acting as the primary liaison across key stakeholders and the project team for all quality-related matters. - Facilitate workshops and training sessions to promote quality awareness and compliance culture. - Monitoring and reporting on quality KPIs and drive continuous improvement initiatives. - Supporting manufacturing, supply chain, and regulatory teams with quality insights to optimise operations What you need to apply: - Over five years of Quality Assurance experience in regulated pharmaceutical and CDMO settings, ensuring compliance and operational excellence. - Extensive experience in ERP implementations, with a strong focus on SAP systems, and familiarity with tools such as SAP Signavio for process modelling and validation traceability. - Demonstrated leadership in CSV activities and QA-related ERP projects. - Experience with AI/ML tools for quality monitoring and validation (desirable). #J-18808-Ljbffr

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