About the Role
We are supporting a leading organisation in the pharmaceutical industry undergoing a key digital supply chain transformation, focused on implementing a Serialization Level 5 system to ensure compliance with US DSCSA regulations.
This is a high-impact role within the Digital Technology function, requiring a hands‑on functional expert capable of bridging IT, Quality, Supply Chain, and external vendors in a global environment.
The solution is an industry‑standard serialization platform (not custom‑built) that must integrate seamlessly into an existing ecosystem, including SAP ATTP (Level 4) and established validation frameworks.
Responsibilities
Act as the Functional Lead for the Level 5 serialization system implementation
Collaborate closely with the solution vendor and system integrator to understand capabilities and constraints
Coordinate cross‑functional stakeholders across:
IT Validation
Quality Assurance (Digital & Business)
Global Supply Chain
Functional System Owners
Lead and contribute hands‑on to CSV deliverables:
URS, FRS, DS, FRA, IQ/OQ/PQ
Ensure alignment with SOPs, validation standards, and documentation frameworks
Plan, track, and coordinate validation and delivery activities
Actively participate in project governance, escalating risks and issues when needed
Work in close collaboration with a business‑side project manager
Profile
Minimum 8+ years of experience in pharma / life sciences (GxP‑regulated environments)
Proven hands‑on expertise in serialization systems (L3‑L5)
Strong experience in Computerized System Validation (CSV)
Experience with at least one of the following:
SAP ATTP
SAP ICH
TraceLink or other Track & Trace platforms
Solid understanding of:
US DSCSA regulations
GS1 standards & EPCIS
Experience in system integration projects, particularly Level 4–Level 5
Hands‑on experience with validation documentation (URS, FRS, DS, IQ/OQ/PQ)
Ability to operate as a Functional Lead (not purely Architect or Project Manager)
Strong stakeholder management across IT, Quality, Supply Chain, and Vendors
Excellent communication skills in English
Nice to Have
Experience with SAP ATTP Level 4 implementations
Prior involvement in US‑market serialization projects
Experience working in global, cross‑functional teams
Exposure across multiple serialization levels (L3, L4, L5)
Experience delivering serialization solutions for the US market
Experience in cross‑functional, international project teams
Project Details
Start Date: ASAP (target June 2026)
Duration: Until December 2026 (extension likely into 2027)
Workload: ~50% (flexible depending on profile)
Location:
Remote within EU time zone
OR Belgium‑based (1 day/week on site in Walloon Brabant)
#J-18808-Ljbffr