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:
o Define and maintain DT project execution plan, milestones, budget and RAID log for the L5 serialization deployment for US DSCSA regulation.
o Coordinate cross-functional teams: SAP Basis, UAM, SAP ATTP functional teams, Computerized System QA, IT Validation.
o Ensure seamless data flow between L4 (SAP ATTP) and L5 Serialization Network layer.
* Computerized System Validation:
o Lead validation lifecycle documentation in close collaboration with Functional System Owner and IT
o Validation expert (URS, FRS, DS, IQ, OQ, PQ..)
o Ensure all validation activities comply with GAMP5 risk based approach and applicable regulations
o (EU Annex 11, 21 CFR Part 11, FMD/ DSCSA or other applicable serialization directives).
o Maintain audit ready documentation throughout the project lifecycle
* Team Management:
o Manage a virtual team including supply chain stakeholders, DT stakeholders (DT solution experts, enterprise application integration, security, enterprise architecture, …) and external consultants.
o Ensure good communication and information sharing within the team, and good relationship with our stakeholders.
* Operational Excellence & System Ownership:
o Ensure the right operational support model and organization are in place to deliver, document and support our Serialization reporting in US market.
o Set up 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
* Experience
* 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 validation) 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 focused 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
#J-18808-Ljbffr