Quality Assurance Lead
| Job Type | Permanent |
| Area | Galway, IrelandMayo, IrelandRoscommon, Ireland |
| Sector | QualityManagement |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 3570 |
| Job Views | 4 |
- Description
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).
- 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).
