Manager Information Systems

In this vital role, you will be a key part of Amgen's Operations Integrated Case Management Team, working closely with Business collaborators, Product Owners, Business Analysts, Developers, and Testers to ensure that Validation strategy and work are produced for IT Systems. This role will be pivotal in ensuring compliance, operational efficiency (run support), and innovation in the management of data validation processes. You will support continuous improvements and automation in products and integrations. This position combines technical expertise, validation experience, and a solid understanding of compliance to support ongoing system audits.

This role also involves working closely with developers and business analysts to ensure that the technical requirements for upcoming developments are thoroughly elaborated and validated.

Roles & Responsibilities

• Collaborate with System Architects and Product Owners to manage Validation, Strategy, and Deliverables.
• Develop and manage test cases, IQ, OQ, PQ protocols, and validation documentation.
• Identify, document, and track defects during the testing process.
• Collaborate with business, subject matter experts, and development teams to resolve defects and validate fixes.
• Ensure all testing and validation activities align with GxP, FDA 21 CFR Part 11, and other regulatory standards.
• Partner with GxP System Quality, IT, and business teams to ensure alignment on validation objectives and testing requirements.
• Offer ongoing support to ensure effective use of the platform.
• Generate reports and dashboards to monitor testing progress, defect trends, and validation status.

What We Expect of You

We are all different, yet we all use our unique contributions to serve patients. The professional we seek has these qualifications:

Basic Qualifications

• Education and Experience:
• Doctorate degree; OR
• Master's degree and 4 to 6 years of Computer Science, IT, or related field experience; OR
• Bachelor's degree and 6 to 8 years of Computer Science, IT, or related field experience; OR
• Diploma and 10 to 12 years of Computer Science, IT, or related field experience.

Functional Skills

Must-Haves

• Experience in DevOps, Continuous Integration, and Continuous Delivery methodologies.
• Excellent communication skills and the ability to interface with Product Managers and business stakeholders to define scope and value for new developments.
• Experience with Document management systems, ServiceNow suite, HP ALM, JIRA, Salesforce, Java, J2EE.

Good to Have

• Extensive experience in the software development lifecycle.
• Experience using and adoption of Scaled Agile Framework (SAFe).
• Strong analytic/critical-thinking and decision-making abilities.
• Broad working knowledge of key IS domains and layers.
• ITIL (preferred).

Soft Skills

• Excellent leadership and team management skills.
• Exceptional collaboration and communication skills.
• High degree of initiative and self-motivation.
• Ability to manage multiple priorities successfully.
• Team-oriented with a focus on achieving team goals.
• Strong presentation, verbal, and written communication skills.
• Excellent analytical and troubleshooting skills.
• Ability to work effectively with global, virtual teams.

Shift Information

This position may require you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.