Serve as the end-to-end Change Owner and Test Manager for the SAP/ERP portfolio, ensuring system changes are compliant with GxP regulations
Job Summary
Serve as the end-to-end Change Owner and Test Manager for the SAP/ERP portfolio, ensuring system changes are compliant with GxP regulations.
Accountable for driving Change controls, risk-based testing strategies, coordinating test execution, managing defects, and ensuring test evidence supports validation and release decisions.
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer.
Matching Summary
Serve as the end-to-end Change Owner and Test Manager for the SAP/ERP portfolio, ensuring system changes are compliant with GxP regulations.
Skills & Requirements
Must-have
SAP/ERP change lifecycle management
GxP regulations compliance
Risk-based testing strategies
Test execution coordination
Defect management
Validation and release support
21 CFR Part 11 / EU Annex 11
ALCOA+ data integrity principles
GAMP 5 and CSA
Nice-to-have
Digital validation and test automation
Global stakeholder collaboration
Continuous process improvement
Award-winning culture
Key Requirements
Master’s degree and 3+ years of experience OR Bachelor’s degree and 5+ years of experience OR Diploma and 8+ years of experience
Experience in Computer Science, IT, or Life Sciences Change/Test Management
CSV/CSA understanding in a GxP-regulated environment
Hands-on experience supporting SAP ERP systems in a GxP-regulated environment
Strong working knowledge of IT Change and Test Management processes
Experience working within SDLC, Agile, Transport Management, and IT-QMS frameworks