SAP Validation and Compliance Manager

Role Overview: As a Specialist IS Business Systems Analyst at Amgen, you will play a vital role in managing and driving the qualification, validation, and compliance activities for the company's SAP ERP systems and platforms. Your responsibilities will include ensuring enterprise-wide ERP solutions meet regulatory requirements, industry standards, and Amgen's IT-QMS policies. You will lead a team of validation and compliance professionals, define and improve validation strategies, and collaborate with cross-functional teams to embed validation and compliance into project lifecycles and daily operations. Additionally, you will champion adoption of digital validation, automation, and AI-driven compliance initiatives to enhance efficiency and reduce errors. Key Responsibilities: - Lead and manage a team responsible for validation and compliance of SAP ERP systems and related platforms - Define, oversee, and improve validation and compliance strategies in alignment with regulatory requirements and industry standards - Drive planning, execution, and approval of validation deliverables such as Validation Plan, Requirements, Specifications, Test scripts, and Validation Report - Ensure ongoing operational compliance of the SAP ERP landscape including Incident Management, Change Control, and Deviation processes - Provide strategic guidance during SAP upgrades, enhancements, and digital transformation programs - Monitor system data integrity, audit trails, user access reviews, and Periodic reviews - Develop frameworks and best practices for consistency and audit-readiness across SAP validation and compliance activities - Serve as the primary audit liaison for SAP ERP systems and lead audit preparation and response to regulator queries Qualifications Required: - Any degree and 8-13 years of Computer Science, IT, or Computerized systems Validation/Assurance experience - At least 3 years of leadership experience in a regulated IT environment - Extensive experience in SAP ERP validation and compliance within a GxP environment - Strong knowledge of regulatory compliance standards such as 21 CFR Part 11, Annex 11, GAMP 5 - Demonstrated expertise in managing Incident, Problem, Change, CAPA, and Deviation processes within SAP ERP systems Additional Company Details: Amgen is a pioneering biotechnology company dedicated to discovering, developing, and delivering innovative medicines to help patients worldwide. With a focus on Oncology, Inflammation, General Medicine, and Rare Disease, Amgen continues to lead the way in healthcare innovation. Joining the Amgen team means contributing to a culture that is collaborative, innovative, and science-based, with a shared mission to serve patients living with serious illnesses.,