DT Serialization Lead: L5 Deployment & Compliance

MSI Pharma; Town of Belgium (WI); On-site; USD 139,000 - 185,000; Full time

Job description

Department:Digital Technology (DT)Location:EuropeEngagement Type:FreelanceJob SummaryThe DT Functional Lead - Serialization System Implementation is responsible for driving the end-to-end delivery of aSerialization Level 5 (L5) systemin a regulated pharmaceutical environment. The role leads the implementation to supportUS DSCSA reporting, ensuring full compliance with Computerized System Validation (CSV) requirements perGAMP 5 / 21 CFR Part 11 / EU Annex 11, and bridges Digital Technology (DT), Operations, Quality, and external vendors to deliver a validated, production-ready system on time and within budget.Key ResponsibilitiesExecution Lead:

• Define and maintain the DT project execution plan, milestones, budget, and RAID log for the L5 serialization deployment for US DSCSA regulation.
• Coordinate cross-functional teams including SAP Basis, UAM, SAP ATTP functional teams, Computerized System QA, and IT Validation.
• Ensure seamless data flow between L4 (SAP ATTP) and the L5 Serialization Network layer

Computerized System Validation (CSV):

• Lead validation lifecycle documentation in collaboration with the Functional System Owner and IT Validation expert, covering URS, FRS, DS, IQ, OQ, PQ and related deliverables.
• Ensure all validation activities comply with the GAMP5 risk-based approach and applicable regulations (EU Annex 11, 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, etc.) and external consultants.
• Ensure effective communication, information sharing within the team, and strong relationships with key stakeholders.

Operational Excellence & System Ownership:

• Ensure the right operational support model and organization are in place to deliver, document, and support Serialization reporting in the US market.
• Develop and implement an appropriate training strategy to ensure users clearly understand the Serialization Network environment and properly use associated systems.

Education & Qualifications:

• Minimum Education:Bachelor's Degree
• Preferred Education:Master's Degree

• Program/project management experience in an international, global, and cross-department environment
• Proven experience managing multi-functional teams within a global organization
• Hands-on Computerized System Validation (CSV) experience
• Demonstrated experience delivering serialization systems (L3–L5)
• Familiarity with GS1 standards, EPCIS, and serialization regulations (FMD, DSCSA, or equivalent)

Competencies & Skills:Specific Skills

• Strong communication and interpersonal skills
• Results-oriented team player
• Analytical mindset

Project & Program Management capabilitiesProblem Solving

• Thorough analytical skills
• Network mindset for problem solving, taking into consideration multiple and diverse impacts of decision making
• Lateral thinker, adaptable and flexible to incorporate change