Join Amgenâs Mission of Serving PatientsÂ
Amgen harnesses the best of biology and technology to fight the worldâs toughest diseases, and make peopleâs lives easier,fullerand longer. We discover, develop,manufactureand deliver innovative medicines to help millions of patients. Amgen helpedestablishthe biotechnology industry more than 40 years ago andremainson thecutting-edgeof innovation, using technology and human genetic data to push beyondwhatâsknown today.
At Amgen, if you feel likeyouârepart of something bigger,itâsbecause you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.Â
Since 1980,weâvehelped pioneer the world of biotech in our fight against the worldâs toughest diseases. With our focus on four therapeutic areas âOncology, Inflammation, General Medicine, and Rare Diseaseâ we reach millions of patients each year. As a member of the Amgen team,youâllhelp make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Â
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities thatlaywithin them,youâllthrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Â
What youwill do
Letâsdo this.Letâschange the world.
In this critical role, you will serve as the end-to-end Change Owner and Test Manager for the SAP/ERP portfolio, ensuring that all system changes are planned, assessed, tested, validated, and released in compliance withGxPregulations, Amgen IT-QMS, and change and test management processes aligned with global best practices.
You will be accountable for drivingChange controls,risk-based testing strategies, coordinating test execution, managing defects, and ensuring test evidence supports validation and release decisions across Amgenâs SAP landscape.
Roles & Responsibilities:
Act as the single point of accountability for SAP ERP changes across projects, enhancements, fixes, and operational maintenance.
Own and execute the change lifecycle including:
Change initiation and classification
Impact and risk assessment
Approval coordination (Change managers,Business,SMEs,Quality, CAB)
Implementation oversight
Post-implementation verification and closure
Ensure all SAP changescomply with:
21 CFR Part 11/EU Annex 11regulations
ALCOA+ data integrity principles
GAMP 5 and CSA (Computer Software Assurance)
Serve as the Test Manager for SAP ERP changes, responsible for planning, coordinating, and overseeing test activities.
Ensure changesmaintaineffective controls for:
User access and segregation of duties
Audit trails and logging
Configuration vs. customization decisions
Define and implement risk-based test strategies aligned with CSA principles, ensuringappropriate testcoverage for:
Functional requirements
Business processes
Compliance and data integrity risks
Ensure development, review, and execution of test assets, including:
Test strategy and test plans
IQ / OQ / PQ or UAT test scripts (as applicable)
Traceability between requirements, risks, tests, and defects
Coordinate testing across SAP platforms including ECC, S/4HANA, BTP, GRC, Solution Manager (SolMan), integrations, and boundary systems.
Oversee defect management, including:
Defect triage and prioritization
Root cause analysis in collaboration with SAP teams
Verification of defect resolution prior to release
Ensure test execution istimely, documented, and audit-ready, supporting release and validation decisions.
Partner withQuality and Complianceto:
Assess validation impact of changes
Definerequired validationand testingdeliverables
Ensure traceability between requirements, risks,changes,testingand release
Coordinate with SAP developers, functional teams, testers, and SMEs to ensure integrated and compliant delivery.
Support release planning, cutover activities, andhypercareasrequired.
Maintain audit-ready documentation and evidence for change, testing, validation, incident, and deviation activities.
Support internal and external audits by providing changeand test-related evidence and responding to audit inquiries.
Identifyopportunities tooptimizechange and test processes, reduce manual effort, and improve cycle time whilemaintainingquality and compliance.
Contribute to digital validation and test automation initiatives, including standardized templates and tooling.
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