Information Systems Sr. Manager - Technology Regulatory Compliance Lead

Information Systems Sr. Manager – Technology Regulatory Compliance Lead 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. Accountable for the computer systems compliance framework of the technology function, ensuring adherence to global regulatory requirements and Amgen procedures. What you will do As the Technology Regulatory Compliance Lead, you will develop and execute the strategy for computer system validation (CSV), regulatory compliance, and inspection readiness, driving a culture of quality and continuous compliance. You will partner closely with key stakeholders, own technology services, drive project execution and operational excellence, and align technology solutions with business needs to enhance efficiency, reliability, and sustained compliance. 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. What we expect of you We are all different, yet we all use unique contributions to serve patients. The professional we seek possesses the following qualifications. 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 and advanced analytics. Foster strong cross‑functional partnerships to build support for initiatives, energize teams, and ensure sustained alignment with business priorities. 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. 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. What you can expect of us The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on relevant skills, experience, and qualifications. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities. 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. 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. #J-18808-Ljbffr Amgen SA