Regional Serialization Lead

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Summary:

Manage the Serialization responsibilities in the European region working closely with the Global System Owner, Business Owner and Regional Packaging Sites. Support and deliver the Serialization Roadmap through governance, addressing the impact of changes and delivering through change control. Ensure optimal system performance and provide exceptional support to sites. Communicate frequently with sponsors and partners at all levels to provide updates on compliance and serialization.

What You Will Do:

Site Based Activity Support (as needed)

Enter data and configuration into site systems. Assist in equipment installation, qualification, and commissioning.

Systems and Processes

Provide leadership for serialization systems supporting configuration, maintenance and testing, partner with IT in coordination of system updates and collaborate with the Engineering and IT teams to ensure uptime and operability.

Documentation

Define global system use, acquire, document and share knowledge solutions and uthor procedures and training documentation in the Document Management systems.

Compliance - Audits

Ensure solutions align with global regulatory requirements (e.g., EU FMD, US DSCSA), stay up to date on evolving legislation, provide regulatory support, conduct internal evaluations to ensure alignment with all compliance requirements and provide serialization support for external site audits including customer and regulatory agencies. 

Knowledge Building, Sharing and Communication

Develop a deep understanding of the deployed Serialization solution, stay informed about trends, changes and preferred solutions related, rovide relevant and timely information to regional and global sites and facilitate and participate in serialization program meetings

Problem Solving - Improvement

Partner with internal teams, external vendors, and trading partners to resolve serialization issues, facilitate global improvements, assist with developing/implementing site improvements abd support cost conscious upgrades delivering improvements without disruption.

Growth Opportunities

Implement programs to measure serialization performance, address exceptions, and ensure systems are functioning as intended and develop and implement Key Performance Indicators

How Will You Get ThereEducation:

• B.Sc. in a Technical Proficiency preferred

Experience: Minimum requirements

• 5 years of pharmaceutical manufacturing and/or packaging experience
• 5 to 7 years direct serialization experience, preferably including Track & Trace

Preferred competencies

• Strong critical thinking and problem-solving.
• Direct-Indirect leadership experience
• Experienced addressing management and internal customers ensuring desired outcomes
• Experience with change processes/controls
• Experience with Computer Systems Validation and Continuous Process Validation
• Experience in protocol and test script preparation
• Experience with product labeling, bar code standards and grading
• Experience with vendor management, including selection & qualification
• Proficient Project Management capabilities.
• Ability to balance multiple priorities
• Excellent verbal and written communication
• Ability to interact with people at all levels of the organization
• Ability to influence internal/external partners
• Strong organization skills.