ERP/SAP Change Owner

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 for SAP/ERPportfolio, ensuring that all system changes are planned, assessed, implemented,validated, and released in compliance withGxPregulations, Amgen IT-QMSand change management processaligned toglobalbest practices.

You will partner closely with Business, ERPproductdelivery teams, Validation, and Quality to enable risk-based, audit-ready, and efficient change execution 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)

• Partner withQuality and Complianceto:

• Assess validation impact of changes

• Assessrequired validation deliverables

• Ensure traceability between requirements, risks, testing, and release

• Support SAP platforms including ECC, S/4HANA, BTP, GRC, SolutionManager(Solman), integrations, and boundary systems.

• Ensure changesmaintaineffective controls for:

• User access and segregation of duties

• Audit trails and logging

• Configuration vs. customization decisions

• Coordinate with SAPdevelopment,functional, testers andSME’sto ensuretimelyand compliantdeploymentof changes.

• Support release planning, cutover activities, andhypercareasrequired.

• Maintain audit-ready documentation and evidence for change, validation, incident, and deviation activities.

• Proactivelyidentifyopportunities to simplifyandoptimizechange processes, reduce rework, and improve cycle time whilemaintainingquality andcompliance.

• Contribute to continuous improvement initiativesacross the Change management, including adoption of digital validation, automation, and standardized templates.

• Support internal and external audits by providing change-related evidence and responding to audit inquiries

What we expectofyou

We are all different, yet we all use our unique contributions to serve patients. 

Basic Qualifications and Experience:

• Master’s degree and3+years of Computer Science, IT/Lifesciences Change Management withComputerized systems Validation/Assurance(CSV/CSA)understandingin aGxPregulated environmentOR

• Bachelor’s degree and5+years of Computer Science,T/Lifesciences Change Management withComputerized systems Validation/Assuranceunderstandingin aGxPregulated e