Chanelle Pharma are excited to share that we are seeking a highly experienced and detail-oriented Quality Assurance ERP Implementation Lead.
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.
As our QA ERP Implementation Lead, your key responsibilities will be as follows:
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.
The essential duties and responsibilities listed above are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.
Skills & Competencies:
Deep knowledge of SAP S/4HANA or SAP Cloud ERP in regulated pharma or CDMO environments.
Hands-on experience with:
Quality Management (QM) module.
Batch management and traceability.
Inspection planning and execution.
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 Quality Assurance (QA) workstreams in large-scale ERP implementations.
Experience with SAP Signavio or similiar tools for process modelling and validation traceability.
Strong communication, leadership, and stakeholder management skills.
Qualifications & Experience:
Over five years of Quality Assurance experience in regulated pharmaceutical and CDMO settings, ensuring compliance and operational excellence.
Extensive experience in ERP implementations, with a strong focus on SAP systems, and familiarity with tools such as 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, including those returning after a career break or with transferable skills from non-traditional career paths, 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.