IT - SAP & Supply - DT Serialization Lead

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

-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