Senior Quality Assurance Manager

4 days ago

Galway, Galway, Ireland beBeeQuality Full time €85,000 - €110,000

**ERP Quality Assurance Expert Wanted**

  • Job Description: A senior quality assurance expert is required for a large-scale ERP implementation project in the pharmaceutical industry. The successful candidate will lead the quality and compliance aspects of an SAP Cloud ERP transformation.

Responsibilities Include:

  • Defining and implementing the QA strategy for SAP ERP in line with regulatory and operational requirements.
  • Establishing and enforcing quality governance frameworks, policies, and procedures.
  • Leading the QA workstream within the SAP S/4HANA Cloud ERP programme, following an Adopt not Adapt methodology.
  • Collaborating with SAP consultants, business stakeholders, and technical teams to embed quality requirements into system design and configuration.
  • Ensuring compliance with GxP regulations, including 21 CFR Part 11 and EU GMP Annex 11.
  • Supporting the Computer System Validation CSV lead and coordinating with external vendors.
  • Reviewing and approving project documentation.
  • Implementing audit trails, electronic signatures, and access controls to guarantee inspection readiness and data integrity.
  • Acting as the main liaison between stakeholders and project teams on all quality-related matters.
  • Facilitating workshops and training sessions to strengthen compliance culture.
  • Monitoring quality KPIs and driving continuous improvement initiatives.
  • Providing quality insights to manufacturing, supply chain, and regulatory teams to optimise operations.

Required Skills and Qualifications:

  • Extensive experience with SAP S/4HANA or SAP Cloud ERP in regulated pharma environments.
  • Practical knowledge of: 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.

Desirable Qualifications:

  • 5+ years of Quality Assurance experience in regulated pharmaceutical 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.

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