SAP Quality & Compliance Lead Dublin, Leinster

Job description

Are you ready to set the quality bar for a global SAP S/4HANA transformation that safeguards patients and strengthens our business? This role leads the quality and compliance strategy behind a mission-critical ERP platform and the integrated systems that keep our operations resilient, compliant, and audit-ready. You will own the Quality Plan from deployment through routine use, aligning with global standards and regulatory expectations while partnering across Quality, IT, system integrators, and business functions. Your work will secure data integrity, assure validated processes, and enable smooth cutover, go-live, hypercare, and beyond. Will you bring the judgment and influence to embed a culture of quality across every interface, data flow, and control? Accountabilities: Quality planning and governance: Develop, lead and manage the Alexion Quality Plan for SAP S/4 HANA deployment and routine use, ensuring alignment with the global S/4 HANA Quality Plan, programme milestones, risks and deployment requirements. Develop and implement the quality and compliance strategies, policies, procedures, frameworks and controls required for the Alexion deployment. Monitor and report quality and compliance performance, including key metrics, risks, issues, actions, trends, audit findings, change controls, integration risks and readiness indicators. Implementation assurance and compliance: Provide implementation assurance across SAP S/4HANA, integrated SAP and non-SAP systems, processes, data, interfaces, testing, documentation, training, change controls, cutover and go-live activities. Ensure systems connected to S/4HANA, including interfaces, data flows, workflows, controls, security and supporting processes, meet applicable quality, regulatory, GxP, data-integrity, validation and business requirements. Conduct audits, assessments and quality reviews to evaluate compliance with internal standards, regulatory requirements, GxP, data, computerised-system validation and ERP controls across S/4HANA and integrated systems. Risk, change control and validation: Identify and address quality and compliance gaps, ensuring corrective and preventative actions are defined, progressed, documented and closed effectively. Raise, progress and close Veeva GPQS change controls, ensuring appropriate assessment, approvals, evidence and traceability. Act as Quality Approver for Veeva GPQS change controls as necessary. Review and sign off testing and validation evidence across S/4HANA and integrated systems, confirming that agreed quality, compliance, integration and business-readiness requirements have been met. Stakeholder engagement and deployment: Collaborate with cross-functional teams and system owners to embed quality and compliance across clinical, manufacturing, finance, operations, technology, data and service-delivery processes. Provide quality and compliance training and guidance to programme teams, system owners, business users and relevant stakeholders. Support cutover, go-live and hypercare, ensuring quality risks, integrated-system compliance, open actions, controls, evidence and regulatory requirements are managed through deployment and stabilisation. Maintain the Quality & Compliance oversight of S/4HANA ERP post implementation. Stay informed of emerging quality, compliance, regulatory, technology and ERP developments, assessing their potential impact on S/4HANA and integrated systems. Promote a culture of quality and compliance through effective communication, engagement, constructive challenge and continuous improvement across Alexion and the Axial programme. Business-as-usual quality and compliance oversight: Own the ongoing Quality and Compliance oversight model for SAP S/4HANA and its integrated systems following implementation, ensuring the validated state and approved control environment are maintained throughout routine use. Oversee the quality impact assessment, approval and implementation of system changes, enhancements, releases, patches, configuration updates and interface changes through established change-control and validation processes. Monitor routine system performance and compliance indicators, including incidents, deviations, data-integrity events, access-control exceptions, failed interfaces, control failures, recurring support issues and overdue actions, ensuring appropriate investigation, escalation and remediation. Provide Quality oversight of user access, role design and segregation-of-duties controls, including periodic access reviews and the timely removal or amendment of inappropriate access. Ensure validated system documentation remains current and inspection-ready, including requirements, risk assessments, specifications, test evidence, traceability, operating procedures, work instructions and training records. Oversee periodic reviews and ongoing control effectiveness assessments for SAP S/4HANA and GxP-relevant integrated systems, confirming that risks, controls, system use and supporting evidence remain appropriate. Provide Quality review and approval for significant incidents, deviations, CAPAs, problem records and root-cause investigations involving S/4HANA or connected systems, and verify the effectiveness of corrective actions. Ensure master data governance, data ownership, data-quality monitoring, audit-trail review and record-retention activities are performed in accordance with approved procedures and applicable data-integrity requirements. Partner with IT service management, process owners, system owners and business teams to define quality expectations for support, maintenance, supplier management, disaster recovery, business continuity and system decommissioning. Maintain readiness for internal audits, regulatory inspections and health-authority requests relating to SAP S/4HANA, ensuring evidence can be retrieved promptly and commitments are tracked to closure. Identify trends and opportunities for continuous improvement while ensuring that operational efficiency changes do not compromise patient safety, product quality, data integrity or regulatory compliance. Essential Skills/Experience: Bachelor’s degree in Quality, Compliance, Life Sciences, Pharmacy, Engineering, Information Systems, Business or a related discipline. Significant experience in quality assurance, compliance, quality systems, audit, risk management, validation or implementation governance within a pharmaceutical, biopharmaceutical, healthcare or other regulated environment. Experience supporting SAP, S/4HANA, ERP, technology or business transformation programmes in a regulated environment. Demonstrated experience assessing and managing compliance across ERP platforms and connected SAP and non-SAP systems, including interfaces, data flows, workflows, controls, validation, security and system dependencies. Strong knowledge of quality plans, quality-management systems, change control, CAPA, audits, testing, validation, data integrity, GxP, computerised-system validation and compliance frameworks. Proven ability to identify, assess, mitigate, monitor and escalate quality, compliance, integration and implementation risks. Exceptional communication, facilitation, influencing and problem-solving skills, with the ability to work across Quality, Compliance, IT, system owners, business functions, programme teams, system integrators and external partners. A strong quality mindset, with a focus on regulatory compliance, integrated-system assurance, implementation quality, evidence-based decision-making, continuous improvement and sustainable adoption. Desirable Skills/Experience : Experience leading quality and compliance activities through cutover, go-live and hypercare for a complex SAP S/4HANA or ERP deployment. Experience with Veeva GPQS change controls and quality evidence management. Experience working with global programme teams, system integrators and multiple integrated-system owners in a complex regulated environment. Why AstraZeneca : Join a company where