Amgen Specialist IS Business System Analyst in Thousand Oaks, California
Amgen is seeking a Specialist Information Systems (IS) Business System Analyst in its main headquarters at Thousand Oaks, CA to join Operations Information Systems (OIS) and will be responsible for providing IS technology leadership for the Quality and Regulatory functions. This Specialist IS Business System Analyst will be the primary IS contact and subject matter expert for specific business capabilities within the Quality Organization. The incumbent will interact frequently with Quality and Regulatory business partners, IS & Quality management, and service delivery partners to improve business capabilities and proactively manage our technology roadmaps.
The Specialist IS Business System Analyst will report to the Senior Manager for Quality and Regulatory Systems and will be based out of Thousand Oaks, California. We are seeking candidates that are excited about serving patients and want to make a meaningful impact at one of the world's leading biotechnology companies.
Key Activities include :
Partner with Quality and IS subject matter experts to develop and proactively manage Technology Roadmaps including new business capabilities, new technologies, software and infrastructure upgrades, SaaS platforms and critical security features.
Manage service delivery partners to ensure system availability per SLA's, and implement proactive measures to reduce the number of incidents and unplanned outages.
Maintain and publish Activity Calendar (including monthly maintenance, enhancement releases) and ensure that it aligns across Quality and other IS systems & stakeholders
Manage service delivery partners to plan & execute production disaster recovery failover and failback.
Provide subject matter expertise in the event of internal and external audits.
Ensure business continuity during critical production issues and ensure the problem management process is effectively followed for root cause, corrective actions, and preventative actions.
Ensure applications and platforms adhere to Amgen corporate and GxP compliance requirements, including execution of periodic reviews.
Manage communications and act as an escalation point for new projects and system issues.
Translate business requirements into functional and non-functional application and service requirements.
Leverage experience to guide project planning, resource allocation, troubleshooting and resolution of complex issues
Provide expertise and support for new projects, feasibility analysis studies or proofs of concept
Maintain vendor relationships and mentor team members
Master's degree and 3 years of Information Systems and/r Business Analysis experience
Bachelor's degree and 5 years of Information Systems and/r Business Analysis experience
Associate's degree and 10 years of Information Systems and/r Business Analysis experience
High school diploma / GED and 12 years of Information Systems and/r Business Analysis experience
Strong verbal and written communication and interpersonal skills.
Experience with global Quality Management Processes including Non-Conformance Management, Corrective and Preventative Action, Change Control, Product Complaints, Supplier Quality Management, Contract Manufacturing Management, Learning Management and Document Management.
Extensive experience in an GxP regulated industry
Extensive Knowledge of Trackwise or other Quality Management Systems
Demonstrated ability to organize, manage, and direct cross-functional teams to address and solve business and technical issues
Exceptional problem solving skills
Project management and business analysis experience
Demonstrated ability to coordinate/lead multiple projects/activities with competing priorities
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.