Global Serialization Technical Analyst

Purpose and Scope:

The Global Serialization Technical Analyst serves as the technical owner and subject matter expert for Astellas' global Level 4 serialization platform and integrations with the associated partner ecosystems. The role is responsible for ensuring the reliable, compliant, and secure operation of serialization services, supporting global regulatory obligations through system administration, incident management, integrations, validation activities, and continuous platform enhancement across internal and external partners.

Responsibilities and Accountabilities:

• Serve as the technical owner for secure, reliable, and compliant integrations between the global Level 4 (L4) serialization platform and external partners, including CMOs, 3PLs, regulatory authorities, and trading partners.
• Collaborate closely with Serialisation Vendor support teams to manage incidents, service requests, and problem resolution activities, ensuring timely escalation and restoration of service for the L4 platform
• Monitor, govern, and report service performance against established Service Level Agreements (SLAs) and Key Performance Indicators (KPIs), driving operational excellence and continuous service improvement.
• Lead software lifecycle activities associated with new compliance requirements, system enhancements, and upgrades, including the authoring of impact assessments, test scripts and other GXP validation, documentation, and deployment in accordance with Astellas System Lifecycle and GxP standards.
• Oversee the day-to-day administration and maintenance of the global serialization platform performed by our Serialisation Support vendor
• Proactively identify, manage, and communicate system issues, risks, and service impacts, providing clear and timely updates to stakeholders during projects, enhancements, outages, and technical upgrades.
• Act as the primary technical point of contact for production and quality environments, ensuring system availability, regulatory compliance, and business continuity for global serialization operations.

Required Qualifications:

• Bachelor’s degree in Information Technology (IT) or Computer Science (CS).
• Minimum of 5+ years demonstrated experience in the healthcare or pharma IT area
• Excellent communication skills, both written and verbal English
• Demonstrated experience working with business, non-technical business users
• Able to support technical upgrade by conducting impact assessment, addressing any issues, support testing, and document changes per the System Life Cycle (SLC) processes in Astellas.
• Ability to engage and manage critical problem and outage situations with high sense of urgency
• Proven working knowledge in serialization system operation
• Proven understanding of EMVS and/or DSCSA compliance

Working Environment

• At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
• Due to time sensitive nature of serialization operation particularly in the US the role requires occasional extended US operational support till 4pm CST (Monday to Thursday)