Information Systems Sr. Manager – Technology Regulatory Compliance Lead

Career Category

Information Systems

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Information Systems Sr. Manager – Technology Regulatory Compliance Lead

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What you will do

Let’s do this. Let’s change the world. 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.

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.

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What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of Information Systems/Technology and/or Engineering experience

OR

Master’s degree and 4 years of Information Systems/Technology and/or Engineering experience

OR

Bachelor’s degree and 6 years of Information Systems/Technology and/or Engineering experience

OR

Associate’s degree and 10 years of Information Systems/Technology and/or Engineering experience

OR

High school diploma / GED and 12