IT SAP & Supply DT Serialization Lead
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Job Summary
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
Bachelors Degree
Masters 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
Required Skills:
Responsible for overseeing the strategy governance and quality of all master data (Vendors Customers Materials) ensuring its accuracy consistency and alignment with business processes across the organization. Requirements: 10 years of experience in global data depth knowledge in Master Data Governance and Strategy Expertise in Data Quality Management knowledge in Data Integration and Architecture Change Management and Data Migration
