ERP/SAP Change Owner and Test Manager

Join Amgen’s Mission of Serving Patients 

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s 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 beyondwhat’sknown today.

At Amgen, if you feel likeyou’repart of something bigger,it’sbecause you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. 

Since 1980,we’vehelped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team,you’llhelp 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. 

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities thatlaywithin them,you’llthrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. 

What youwill do

Let’sdo this.Let’schange 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 Amgen’s 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.