Specialist IS Business Systems Analyst
Amgen Inc
Amgen seeks a specialist business systems analyst to serve as a subject matter expert in computer system validation, regulatory compliance, and data integrity for the Technology organization in North Carolina. The role involves partnering with cross-functional teams to ensure adherence to global quality standards, support inspection readiness, and optimize compliant digital platform implementations.
Responsibilities
- Serve as SME in computer system validation, regulatory compliance, and data integrity for Technology organization
- Partner with business teams to identify process bottlenecks and optimization opportunities while maintaining compliance
- Support inspection readiness activities including playbook development, documentation, and readiness tracking
- Provide validation and compliance oversight for digital platform implementations and system deployments
- Collaborate with cross-functional teams to develop strategies supporting CSV and sustained inspection readiness
Requirements
- Doctorate degree, or Master's degree with 2+ years IS/Engineering experience
- Deep knowledge of computer system validation, regulatory compliance, and inspection readiness
- Prior experience in biotechnology, pharmaceutical, or regulated industries strongly preferred
- Strong verbal, written, and presentation skills for stakeholder engagement
- Critical thinking and problem-solving ability to design scalable solutions
- Experience with computerized systems lifecycle and data integrity practices
Vacancy posted 6 days ago
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