Information Systems Sr. Manager – Technology Regulatory Compliance Lead

Amgen; Holly Springs (NC); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Comprehensive employee benefits package

Discretionary annual bonus program

Flexible work models

Job summary

Amgen is seeking an Information Systems Sr. Manager to lead technology regulatory compliance in Holly Springs, North Carolina. This position involves overseeing computer systems compliance and ensuring alignment with global quality standards.

The ideal candidate will have extensive experience in regulatory compliance, project management, and team leadership. You will collaborate with key stakeholders to deliver effective technology solutions and drive operational excellence within the organization.

Amgen offers competitive benefits, including a comprehensive employee package and flexible work arrangements.

Qualifications

• Experience in Information Systems, Technology or Engineering.
• Hands-on experience in computer validation and regulatory compliance.
• Strong verbal, written, and presentation skills.

Responsibilities

• Lead the strategy for computer system validation and regulatory compliance.
• Drive inspection readiness efforts.
• Manage digital technology services with a focus on reliability.

Skills

Project management

Regulatory compliance

Cross-functional leadership

Critical thinking

Education

Doctorate degree in Information Systems or related field

Master's degree in Information Systems or related field

Bachelor's degree in Information Systems or related field

Associate's degree in Information Systems or related field

High school diploma / GED

Job description

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.

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.

Basic Qualifications

• 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

Preferred Qualifications

• 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 emerging tools and technologies, actively contribute to professional communities, and foster a culture of innovation.
• Apply critical thinking and best practices to proactively resolve complex issues and design effective, scalable solutions.
• Demonstrate strong verbal, written, and presentation skills to engage stakeholders, senior management and lead teams effectively.
• Clearly articulate the rationale behind decisions and their potential implications, continuously reflecting on successes and failures to enhance performance and decision‑making.
• Recognize the need for change and actively participate in technical strategy planning.
• Manage multiple initiatives with strong organizational skills, ensuring alignment with team goals and measurable performance outcomes.

Benefits

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save toward retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan.
• Stock‑based long‑term incentives.
• Award‑winning time‑off plans and bi‑annual company‑wide shutdowns.
• Flexible work models, including remote work arrangements, where possible.

Application Information

Application deadline: Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Equal Opportunity Employer

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.