ERP Change Owner
Amgen · Hyderabad · onsite · Posted 66d ago
Undisclosed3–7 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
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
Sourced from naukri
Skills
SDLCScrum masterSAPAutomationServicenowAgileScrumerp systemsrChange ManagementRisk AssessmentERP
About Amgen
Amgen
Biotechnology
1.5k+
employees
1980
46 years old
Hyderabad, Telangana
India
About
Amgen operates in the biotechnology sector, developing and delivering advanced medicines to address critical health challenges globally.
Industries
BiotechnologyBiotech & Life sciences
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Culture
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