Information Systems Sr. Manager – Technology Regulatory Compliance Lead

Role Summary

Information Systems Sr. Manager – Technology Regulatory Compliance Lead responsible for delivering high-quality digital technologies within the Technology Organization and ensuring compliance with global regulatory requirements and Amgen procedures. You will lead the strategy for computer system validation, regulatory compliance, and inspection readiness, and serve as Technology Regulatory Compliance Lead. You will report to the ANC Site Technology Lead Director as a member of the Technology Leadership Team.

Responsibilities

• Lead the development and execution of the strategy for computer system validation, regulatory compliance, and sustained inspection readiness for the Technology organization.
• Serve as the Technology Regulatory Inspection Lead, ensuring alignment with global quality and compliance strategies.
• Drive inspection readiness efforts, including playbooks, SME coaching, system documentation, and readiness dashboards.
• Oversee digital platform implementations, ensuring strong planning, resource management, risk mitigation, and financial oversight.
• Manage digital technology services, including validation, compliance, data integrity, and system reliability.
• Design and implement effective support models, including vendor and third-party management with clear accountability.
• Lead cross-functional teams, run key meetings, and present updates to senior leadership.
• Deliver technology solutions that improve efficiency, quality, and business alignment.
• Proactively manage complex, simultaneous projects and resolve challenges effectively.
• Establish performance metrics to drive continuous improvement.
• Ensure successful project delivery and promote operational excellence.
• Mentor team members and serve as subject matter experts.
• Stay current on industry and technology trends and build external networks to benchmark best practices.

Qualifications

• Required: Doctorate degree and 2 years of Information Systems/Technology and/or Engineering experience
• Required: Master’s degree and 4 years of Information Systems/Technology and/or Engineering experience
• Required: Bachelor’s degree and 6 years of Information Systems/Technology and/or Engineering experience
• Required: Associate’s degree and 10 years of Information Systems/Technology and/or Engineering experience
• Required: High school diploma / GED and 12 years of Information Systems/Technology and/or Engineering experience
• Preferred: Industry Experience Preferred: Prior experience in biotechnology, pharmaceutical, or related regulated industries is strongly preferred.
• Preferred: Depth knowledge and hand on experience in computer validation, regulatory compliance, inspection readiness.
• Preferred: Bridge Vision and Execution: Translate operational goals into actionable strategies across manufacturing, laboratory, supply chain, quality, engineering, and technology functions using digital technologies, data, advanced analytics.
• Preferred: Lead Through Influence and Collaboration: Foster strong cross-functional partnerships to build support for initiatives, energize teams, ensure sustained alignment and focus on business priorities and goals.
• Preferred: Think Strategically: Anticipate impacts, adapt to change, and make well-reasoned decisions that drive continuous improvement and support business needs.
• Preferred: Champion Continuous Learning: Stay current with emerging tools and technologies, actively contribute to professional communities, and foster a culture of innovation.
• Preferred: Drive Problem Solving and Innovation: Apply critical thinking and best practices to proactively resolve complex issues and design effective, scalable solutions.
• Preferred: Communicate with Clarity: Demonstrate strong verbal, written, and presentation skills to engage stakeholders, senior management and lead teams effectively.
• Preferred: Decision-Making: Clearly articulate the rationale behind decisions and their potential implications, continuously reflecting on successes and failures to enhance performance and decision-making.
• Preferred: Adaptive Leadership: Recognizes the need for change and actively participates in technical strategy planning.
• Preferred: Balance Priorities: Manage multiple initiatives with strong organizational skills, ensuring alignment with team goals and measurable performance outcomes.