Overview
Team Horizon is seeking a Quality Lead who will oversee the quality and compliance aspects of a SAP Cloud ERP transformation. This is a critical position to ensure GxP compliance, data integrity, and operational excellence across developing and growing pharmaceutical operations.
Why you should apply
* Work with an Industry Leader with Global Reach, exporting to over 90 countries and holding thousands of product licenses in both human and animal health.
* Career Growth & Development, benefit from strong investment in employee training and professional development, with opportunities to grow within a rapidly expanding and internationally recognized business.
* Modern Facilities & Regulatory Excellence, Gain experience in FDA-approved, high-standard manufacturing and R&D environments, supporting innovation and quality in pharmaceutical production.
What you will be doing
* 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. Facilitating workshops and training sessions to promote quality awareness and compliance culture.
* Monitoring and reporting on quality KPIs and driving continuous improvement initiatives.
* Supporting manufacturing, supply chain, and regulatory teams with quality insights to optimise operations.
What you need to apply
* 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).
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