Information Systems Sr. Manager – Technology Regulatory Compliance Lead
Amgen · Holly Springs, NC
RegulatoryFull-timeCompany career page
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Role summary
This senior management role leads technology regulatory compliance and computer system validation strategy for Amgen's technology organization. The position ensures adherence to global regulatory requirements, drives inspection readiness, and oversees digital platform implementations while maintaining operational excellence and service quality across technology services.
What they're looking for
- Bachelor's degree plus 6 years of Information Systems/Technology/Engineering experience
- Prior experience in biotechnology, pharmaceutical, or regulated industries strongly preferred
- Hands-on expertise in computer system validation and regulatory compliance
- Demonstrated ability to lead cross-functional teams and drive strategic initiatives
- Strong knowledge of inspection readiness processes and compliance frameworks
What you'll be doing
- Lead development and execution of computer system validation and regulatory compliance strategy
- Serve as Technology Regulatory Inspection Lead ensuring alignment with global quality standards
- Drive inspection readiness efforts including documentation, dashboards, and team coaching
- Oversee digital platform implementations with resource and financial management oversight
- Mentor team members and establish performance metrics for continuous improvement
Privacy & handoff
This role links to Amgen's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.