EU Serialization Lead

Thermo Fisher Scientific Visualizza tutti gli annunci

Milano
Tempo indeterminato
Full time

24 giorni fa

Work Schedule Standard (Mon-Fri)Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, OfficeJob DescriptionAs part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges.DESCRIPTION:The EU Serialization Lead plays a critical role in protecting patients and securing the pharmaceutical supply chain by ensuring compliant, reliable serialization and track & trace solutions across our global manufacturing network. This position serves as the Regional Serialization Lead for Europe, supporting global serialization initiatives across internal manufacturing sites and external partners (clients, 3PLs, wholesalers).Working closely with cross-functional teams including Global Operations, IT, Engineering, Quality, Regulatory Affairs, and external vendors, you'll execute the global serialization roadmap, ensure compliance with EU FMD, US DSCSA, and other global regulations, and provide hands-on system and operational support to sites. You'll support Thermo Fisher Scientific's mission by implementing effective serialization solutions that help make the world healthier, cleaner, and safer.Key Responsibilities:

Lead and support serialization activities across European sites; provide backup support for North America
Execute the global serialization roadmap and participate in change management governance
Ensure compliance with EU FMD, DSCSA, and other global Track & Trace regulations
Support system configuration, master data setup, validation (CSV/CPV), and change control activities
Troubleshoot serialization and aggregation issues with sites and trading partners
Collaborate with IT and Engineering to ensure system uptime and performance (Level 1–4 architecture)
Develop and maintain SOPs, training materials, and global documentation
Support regulatory inspections, customer audits, and internal compliance reviews
Monitor serialization KPIs and drive continuous improvement initiatives

REQUIREMENTS:Minimum Qualifications:

5+ years pharmaceutical manufacturing and/or packaging experience
5–7 years direct pharmaceutical serialization experience, including Track & Trace
Strong knowledge of EU FMD and US DSCSA
Experience with Computer Systems Validation (CSV) and pharmaceutical change management
Experience with protocol/test script development and validation activities
Knowledge of labeling requirements, barcode standards, and barcode grading
Strong project management and problem-solving skills
Ability to manage multiple priorities in a global environment
Excellent written and verbal English communication skills

Preferred Qualifications:

Bachelor's degree in a technical discipline (Engineering, Computer Science, or related field)
Vendor management and qualification experience
Experience supporting global, multi-site serialization programs
French or Italian language skills a plus
Lean, Six Sigma, or PPI experience

What We Value:

Commitment to quality, compliance, and patient safety
Strong collaboration and stakeholder influence skills
Ownership mindset with results-driven execution
Data-driven problem solving and continuous improvement focus
Digital fluency and systems agility

Additional Information:

Work Schedule: Standard (Mon–Fri)
Travel: Up to 20%
Location: EU-based

This is an opportunity to take a leadership role in advancing global pharmaceutical traceability while supporting critical compliance initiatives across an international network.

Thermo Fisher Scientific

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