Quality Assurance Lead – ERP Implementation Project

Description

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 Responsibilities

• Define 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 & Competencies

• In-depth knowledge of SAP S/4HANA or SAP Cloud ERP in regulated pharma or CDMO environments.

• Practical experience with:

  • Quality Management (QM) module

  • Batch management and traceability

  • Inspection planning and execution

  • Integration with LIMS and EQMS

• Familiarity 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 & Experience

• 5+ 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).