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