PURPOSE Lead the end to end implementation of a Serialization Level 5 system to support US DSCSA reporting, ensuring full compliance with Computerized system Validation ( CSV) requirements per GAMP 5 / 21 CFR Part 11 / EU Annex 11. The role bridges Digital Technology (DT), Operations, Quality and external vendors to deliver a validated, production ready system on time and within budget. Key responsibilities Execution Lead: • Define and maintain DT project execution plan, milestones, budget and RAID log for the L5 serialization deployment for US DSCSA regulation. • Coordinate cross-functional teams: SAP Basis, UAM, SAP ATTP functional teams, Computerized System QA, IT Validation. • Ensure seamless data flow between L4 (SAP ATTP) and L5 Serialization Network layer. Computerized System Validation: • Lead validation lifecycle documentation in close collaboration with Functional System Owner and IT Validation expert ( URS, FRS, DS, IQ, OQ, PQ..) • Ensure all validation activities comply with GAMP5 risk based approach and applicable regulations (EU Annex 11m 21 CFR Part 11, FMD/ DSCSA or other applicable serialization directives). • Maintain audit ready documentation throughout the project lifecycle Team Management: • Manage a virtual team including supply chain stakeholders, DT stakeholders (DT solution experts, enterprise application integration, security, enterprise architecture, …) and external consultants. • Ensure good communication and information sharing within the team, and good relationship with our stakeholders. Operational Excellence & System Ownership: • Ensure the right operational support model and organization are in place to deliver, document and support out Serialization reporting in US market. • Setup together with our stakeholders the appropriate training strategy to make sure the users clearly understand the Serialization Network environment and properly use the associated systems. Requirements EDUCATION & QUALIFICATION Bachelor's Degree Master's Degree Experience -Program/project management in an international, global and cross-department environment - Experience in managing multi-functional teams in a global organization - Hands-on CSV ( computerized system valiation) experience - Proven experience delivering serialization systems ( L3-L5) - Familiarity with GS1 standards, EPCIS and serialization regulations ( FMD, DSCSA or equivalent) Specific skills - Good communication skills - Team player strongly focussed on providing results - Analytical mind - Project & Program Management capabilities Problem solving - Thorough analytical skills - Network mindset for problem solving taking into consideration multiple and diverse impacts of decision making - Lateral thinker, adaptable & flexible to incorporate change