About the Role
Scroll down to find the complete details of the job offer, including experience required and associated duties and tasks.
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 xlxgzvr 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)
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