Serialization SME Technical Project Manager

POSITION SUMMARY:

RDP is looking for a Technical Serialization Subject Manager Expert and Serialization SME/PM to lead the technical implementation of the Global Serialization (L4) system that is in the cloud (vendor hosted). The Serialization SME/PM will interact with the serialization vendor teams to address questions and ensure requirements are met. The Serialization SME/PM will assist in requirements definition, design and testing including the development of test scripts. This person will also oversee end-to-end User Acceptance Testing (UAT) activities, Integrations with 3rd party systems and CMO's.

ESSENTIAL JOB RESPONSIBILITIES:

Lead and support the implementation of both emerging and changing global serialization & traceability regulations, industry standards (e.g. GS1) and determining the impacts of these on existing implementations. The main responsibility for this role is to lead the RDP support for implementation of serialization compliance regulations for Brazil ANVISA, Integration with brazil 3PL (Luft), Bahrain, China, Russia updates, US Drug Supply Chain and Security Act's verifiable Saleable Returns (VRS) and interoperability of serialization systems as per DSCSA 2023 deadlines and other serialization initiatives (integration with external partners as Recordati for disinvestment) through each of the following phases:

Analysis and Planning Phase:

Draft SDLC documents and route them for all stakeholder review and approval

Design Phase:

Develop Deliverables through guidance, coordination and facilitation of reviews and approvals. Coordinate / Collaborate with internal and external partners to ensure most efficient design. Work with contract manufacturers to ensure technical and business processes are in line with Astellas requirements. Lead design workshops with internal and

Build/Dev/Test Phase:

Support development of Deliverables through guidance, coordination and facilitation of reviews and approvals. Identify resources required to draft and execute Operation Verification (OV) test scripts. Guide resources in script development

Testing/Acceptance Phase:

Ensure all business scenarios are covered in test scripts. Oversee and troubleshoot test execution. Coordinate / collaborate with QA resources and facilitate reviews and approvals.

Deploy Phase:

Confirm all validation activities are complete and rfXcel PROD system is successfully upgraded with Russian requirements