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 There
Education:
- 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.
