Overview
Chanelle Pharma are excited to share that we are seeking a highly experienced and detail-oriented Quality Assurance Lead for our upcoming ERP Implementation Project. The role will involve overseeing the quality and compliance aspects of our SAP Cloud ERP transformation. This is a critical position to ensuring GxP compliance, data integrity, and operational excellence across our developing and growing pharmaceutical operations.
Location
Onsite in our QC Laboratory in Loughrea, Co. Galway.
Responsibilities
* 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.
Qualifications/Skills
* Deep knowledge of SAP S/4HANA or SAP Cloud ERP in regulated pharma or CDMO environments.
* Hands-on experience with:
o Quality Management (QM) module.
o Batch management and traceability.
o Inspection planning and execution.
o Business process 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 Computer System Validation (CSV) and audit readiness.
* Proven track record leading QA workstreams in large-scale ERP implementations.
* Experience with SAP Signavio or similar tools for process modelling and validation traceability.
* Strong communication, leadership, and stakeholder management skills.
* Qualifications: Over five years of Quality Assurance experience in regulated pharmaceutical and CDMO settings, ensuring compliance and operational excellence.
* Extensive experience in ERP implementations with SAP systems, and familiarity with 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).
* Applicants from diverse backgrounds are encouraged to apply. We value varied experiences and are committed to fostering an inclusive environment that supports individuals with disabilities.
* This position is only open to candidates who already hold valid work authorisation for the EU.
Additional
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Quality Assurance
* Industries: Pharmaceutical Manufacturing
#J-18808-Ljbffr