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).