ERP Change Owner

What you will do

Lets do this. Lets change the world.

In this critical role, you will serve as the end-to-end Change Owner for SAP / ERP portfolio , ensuring that all system changes are planned, assessed, implemented, validated , and released in compliance with GxP regulations, Amgen IT-QMS and change management process aligned to global best practices .

You will partner closely with Business, ERP product delivery teams, Validation, and Quality to enable risk-based, audit-ready, and efficient change execution across Amgens 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 changes comply with :

• 21 CFR Part 11 / EU Annex 11 regulations

• ALCOA+ data integrity principles

• GAMP 5 and CSA (Computer Software Assurance)

• Partner with Quality and Compliance to:

• Assess validation impact of changes

• Assess required validation deliverables

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

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

• Ensure changes maintain effective controls for:

• User access and segregation of duties

• Audit trails and logging

• Configuration vs. customization decisions

• Coordinate with SAP development, functional , testers and SMEs to ensure timely and compliant deployment of changes.

• Support release planning, cutover activities, and hypercare as required .

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

• Proactively identify opportunities to simplify and optimize change processes, reduce rework, and improve cycle time while maintaining quality and compliance.

• Contribute to continuous improvement initiatives across 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 expect of you

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

Basic Qualifications and Experience:

• Masters degree and 3 + years of Computer Science, IT /Lifesciences Change Management with Computerized systems Validation/ Assurance ( CSV/CSA) understanding in a G x P regulated environment OR

• Bachelors degree and 5 + years of Computer Science, T /Lifesciences Change Management with Computerized systems Validation/Assurance understanding in a G x P regulated environment OR

• Diploma and 8 + years of Computer Science, I T /Lifesciences Change Management with Computerized systems Validation/Assurance understanding in a G x P regulated environment .

• Hands-on experience supporting SAP ERP systems in a GxP -regulated environment

• Strong working knowledge of:

• IT Change Management

• Strong understanding of SAP ERP landscapes

• Validation and compliance processes

• Regulatory requirements (21 CFR Part 11, Annex 11, ALCOA+, GAMP 5)

• Experience working within structured SDLC , Agile , Transport Management and IT-QMS frameworks.

Preferred Qualifications:

• Experience supporting SAP transformation initiatives ( Ex: R/3 to ECC and/or ECC to S/4HANA upgrades ).

• Familiarity with CSA-aligned, risk-based validation approaches and Hands on experience preparing change and validation documentation .

• Experience working with ITSM and change management tools ( Ex ., ServiceNow , Solman ).

• Exposure to audits or inspections supporting SAP systems.

• Experience working in global, matrixed teams.

Professional Certifications

• Scrum Master or equivalent

• ITIL / Change Management certification

Soft Skills:

• Strong sense of ownership and accountability

• Excellent communication and stakeholder-management skills

• Ability to balance compliance requirements with business agility

• Structured, detail-oriented, and risk-aware mindset

• Comfortable working across Business, IT, and Quality teams