**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.