Information Systems Sr. Manager Technology Regulatory Compliance Lead

Join Amgen's Mission of Serving Patients At Amgen, we are part of something bigger. Our shared mission to serve patients living with serious illnesses drives all that we do. Information Systems Sr. Manager Technology Regulatory Compliance Lead Live 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 sites 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. What We Expect Of You Basic Qualifications Doctorate degree and 2 years of information systems/technology and/or engineering experience. Masters 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. Depth knowledge and hands‑on experience in computer validation, regulatory compliance, and inspection readiness. Translate operational goals into actionable strategies across manufacturing, laboratory, supply chain, quality, engineering, and technology functions using digital technologies, data, advanced analytics. Lead through influence and collaboration: foster strong cross‑functional partnerships to build support for initiatives and energize teams. Think strategically: anticipate impacts, adapt to change, and make well‑reasoned decisions that drive continuous improvement and support business needs. Champion continuous learning: stay current with emerging tools and technologies, actively contribute to professional communities, and foster a culture of innovation. Drive problem solving and innovation: apply critical thinking and best practices to proactively resolve complex issues and design effective, scalable solutions. Communicate with clarity: demonstrate strong verbal, written, and presentation skills to engage stakeholders, senior management, and lead teams effectively. Decision‑making: articulate the rationale behind decisions and their potential implications, continuously reflecting on successes and failures to enhance performance. Adaptive leadership: recognize the need for change and actively participate in technical strategy planning. Balance priorities: manage multiple initiatives with strong organizational skills, ensuring alignment with team goals and measurable performance outcomes. What You Can Expect Of Us We support professional and personal growth and well‑being. The expected annual salary range for this role in the U.S. is posted. Actual salary will vary based on experience and qualifications. Amgen offers a total rewards plan comprising health and welfare plans for staff and eligible dependents, financial plans with retirement savings opportunities, work/life balance, and career development. Benefits include: 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. 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 Deadline Amgen does not have an application deadline for this position; applications are accepted until a sufficient number are received or a candidate is selected. Equal Opportunity Employer Amgen is an Equal Opportunity employer and will consider you without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will provide reasonable accommodation for individuals with disabilities to participate in the job application and interview process. #J-18808-Ljbffr BioSpace