Specialist IS Business Systems Analyst

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. 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 lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Specialist IS Business Systems Analyst – Technology Computer Validation SME What you will do Let’s do this. Let’s change the world. In this vital role, you will join the Amgen North Carolina (ANC) Technology team as an individual [... source excerpt omitted ...] g opportunities to streamline, optimize, and automate processes where appropriate. You will support the Computer Systems Compliance team by ensuring adherence to global regulatory requirements and Amgen procedures. Acting as a subject matter expert (SME) in computer system validation (CSV), regulatory compliance, data integrity, quality systems and inspection readiness, you will partner with the business to maintain reliable, compliant and efficient systems. You will proactively promote a culture of quality and continuous compliance, ensuring alignment with global quality standards and sustaining a constant state of inspection readiness. This position reports directly to the ANC Te [... source excerpt omitted ...] ing, 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 tra