EU Serialization Lead

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

As 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.