Specialist IS Business Systems Analyst

About the role

Join Amgens 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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 lie within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Responsibilities

• Serve as a subject matter expert (SME) in computer system validation (CSV), regulatory compliance, data integrity, quality systems, and inspection readiness for the Technology organization.
• Contribute to the development and execution of strategies supporting CSV, regulatory compliance, and sustained inspection readiness.
• Partner with cross-functional teams to ensure alignment with global quality and compliance standards and practices.
• Support inspection readiness activities, including development of playbooks, SME guidance, system documentation, and readiness tracking tools.
• Provide compliance and validation oversight for digital platform implementations, ensuring appropriate planning, risk identification, and adherence to regulatory expectations.
• Support digital technology services by ensuring validation, compliance, data integrity, and system reliability requirements are met.
• Collaborate in the design and implementation of support models, including coordination with vendors and third-party providers.
• Participate in cross-functional initiatives, contributing expertise in meetings and providing updates to stakeholders as needed.
• Help deliver solutions that enhance efficiency, quality, and alignment with business objectives.
• Manage multiple priorities and contribute to resolving complex compliance and validation challenges.
• Support the development and tracking of performance metrics to enable continuous improvement.
• Contribute to successful project execution and promote operational excellence.
• Stay current with industry trends, regulatory expectations, and emerging technologies to inform best practices.

Qualifications

• Doctorate degree OR Masters degree and 2 years of Information Systems or Engineering experience OR Bachelors degree and 4 years of Information Systems or Engineering experience OR Associates degree and 8 years of Information Systems or Engineering experience OR High school diploma / GED and 10 years Information Systems or Engineering experience
• Industry experience preferred: 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.
• 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: Clearly articulate the rationale behind decisions and their potential implications, continuously reflecting on successes and failures to enhance performance and decision-making.
• 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.

Benefits

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a total rewards plan, based on eligibility, comprising of 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. Refer to the Work Location Type in the job posting to see if this applies.