Tech Regulatory Compliance Lead — Senior IS Manager | Remote

Amgen; Holly Springs (NC); On-site; USD 135,000 - 183,000; Full time

Benefits offered by this job

Remote work options

Total Rewards Plan

Career development opportunities

Job summary

Amgen in the United States seeks an Information Systems Sr. Manager – Technology Regulatory Compliance Lead to steer the strategy for computer system validation and global regulatory compliance, ensuring inspection readiness and alignment with Amgen quality standards.

You will lead cross‑functional teams, drive validation, data integrity, and appropriate governance for digital platforms, and partner with senior stakeholders to deliver reliable, compliant technology solutions that advance patient

Qualifications

• PhD or master’s degree in information systems, engineering, or a related field.
• Experience in information systems regulatory compliance in biotech/pharma preferred.
• Strong leadership and communication skills.

Responsibilities

• Lead the strategy for computer system validation, regulatory compliance, and inspection readiness.
• Serve as Technology Regulatory Inspection Lead, aligning with quality strategies.
• Drive inspection readiness playbooks, dashboards, and SME coaching.
• Oversee digital platform implementations with risk and financial oversight.
• Mentor team members and present updates to senior leadership.
• Stay current on industry trends and benchmark best practices.

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Job description

Amgen in the United States seeks an Information Systems Sr. Manager – Technology Regulatory Compliance Lead to steer the strategy for computer system validation and global regulatory compliance, ensuring inspection readiness and alignment with Amgen quality standards.

You will lead cross‑functional teams, drive validation, data integrity, and appropriate governance for digital platforms, and partner with senior stakeholders to deliver reliable, compliant technology solutions that advance patient