SAP Quality & Compliance Lead

About the role

AstraZeneca's Alexion team is looking for a SAP Quality & Compliance Lead to own the quality and compliance strategy behind a mission-critical SAP S/4HANA deployment and the integrated systems that keep operations resilient, compliant and audit-ready. The role covers the Quality Plan from deployment through routine use, working with Quality, IT, system integrators and business functions to secure data integrity, validated processes and a culture of quality.

Key responsibilities

• Lead and manage the Alexion Quality Plan for the S/4HANA deployment and routine use, aligned with global standards and regulatory expectations
• Implement quality and compliance strategies, policies, procedures, frameworks and controls
• Monitor and report quality and compliance performance, including metrics, risks, audit findings and change controls
• Provide implementation assurance across SAP S/4HANA, integrated SAP and non-SAP systems, interfaces, testing, documentation, training, cutover and go-live
• Conduct audits, assessments and quality reviews against GxP, data-integrity and validation requirements
• Manage Veeva GPQS change controls, act as Quality Approver where needed, and sign off testing and validation evidence
• Support cutover, go-live and hypercare, then maintain quality oversight after implementation
• Oversee quality impact assessments of system changes, user access and segregation of duties, and incident, deviation and CAPA reviews
• Keep validated documentation current, ensure master data governance and audit readiness, and promote continuous improvement

Required profile

• Bachelor's degree in Quality, Compliance, Life Sciences, Pharmacy, Engineering, Information Systems, Business or a related discipline
• Significant experience in QA, compliance, quality systems, audit, risk management, validation or implementation governance in a regulated environment
• Experience supporting SAP, S/4HANA, ERP or business transformation programmes in a regulated setting
• Demonstrated experience managing compliance across ERP platforms and connected systems

Required skills

• Strong knowledge of quality plans, quality-management systems, change control, CAPA, audits, testing, validation, data integrity, GxP and computerised-system validation
• Ability to identify, assess, mitigate and escalate quality, compliance and integration risks
• Desirable: experience with Veeva GPQS change controls and leading quality and compliance through cutover, go-live and hypercare