Information Systems Sr. Manager – Technology Regulatory Compliance Lead

Information Systems Sr. Manager – Technology Regulatory Compliance Lead What You Will Do

In this vital role, you will lead the delivery of high‑quality, robust, and reliable digital technologies and services within the Technology Organization, ensuring seamless support for business, project, and daily operations. You will be accountable for the computer systems compliance framework of the technology function, ensuring adherence to global regulatory requirements and Amgen procedures.

You will lead the strategy for computer system validation (CSV), regulatory compliance, and inspection readiness for the technology team, proactively driving a culture of quality and continuous compliance. Serving as the Technology Regulatory Compliance Lead, you will ensure alignment with global quality and compliance strategies and maintain a state of constant inspection readiness.

Partnering closely with key stakeholders, you will take full ownership of technology services, driving both project execution and operational excellence. Your focus will be on aligning technology solutions with business needs, continuously optimizing approaches to enhance efficiency, and ensuring reliability, service quality, and sustained compliance for our partners.

As Senior Manager of the Technology Department for ANC, you will report directly to the ANC Site Technology Lead Director. This role serves as a key member of the site’s Technology Leadership Team, driving innovation, operational excellence, quality, compliance, and measurable business impact through strategic technology leadership.

• 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.

• Doctorate degree and 2 years of Information Systems / Technology and/or Engineering experience
• Master’s degree and 4 years of Information Systems / Technology and/or Engineering experience
• Bachelor’s degree and 6 years of Information Systems / Technology and/or Engineering experience
• Associate’s degree and 10 years of Information Systems / Technology and/or Engineering experience
• High school diploma / GED and 12 years of Information Systems / Technology and/or Engineering experience

• Prior experience in biotechnology, pharmaceutical, or related regulated industries is strongly preferred.
• Depth knowledge and hands‑on experience in computer validation, regulatory compliance, inspection readiness.
• Translate operational goals into actionable strategies across manufacturing, laboratory, supply chain, quality, engineering, and technology functions using digital technologies, data, advanced analytics.
• Foster strong cross‑functional partnerships to build support for initiatives, energize teams, ensure sustained alignment and focus on business priorities and goals.
• Anticipate impacts, adapt to change, and make well‑reasoned decisions that drive continuous improvement and support business needs.
• Stay current with…