Department: Digital Technology (DT) Location: Europe
Engagement Type: Freelance
Job Summary
The DT Functional Lead – Serialization System Implementation is responsible for driving the end-to-end delivery of a Serialization Level 5 (L5) system in a regulated pharmaceutical environment. The role leads the implementation to support US DSCSA reporting, ensuring full compliance with Computerized System Validation (CSV) requirements per GAMP 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 Responsibilities
Execution 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 capabilities
Problem 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