The Senior Manager Product Traceability and Serialization leads serialization, product traceability oversight, alert management, process improvement and governance for the Alexion AstraZeneca Rare Disease Unit. This business-critical position holds overall accountability for product traceability and compliance with regulations such as DSCSA and EU FMD. The role ensures that product traceability systems, processes and standards are developed, implemented and tested in line with global standards and regulatory expectations. Acting as the main point of contact in Alexion for product serialization, serial number management, product traceability and compliance with regulations and industry standards, this position supports global launches and alignment with key partners to meet regional requirements. A strong understanding of the processes and systems needed to support traceability across production, warehouse and distribution functions is essential. As the business process owner for Serialization and Product Traceability, this role provides mentorship and direction to functional subject matter experts.

Accountabilities

Lead the Alexion Product Traceability and Serialization forum and activities, collaborating with Supply Chain, Manufacturing, QA, Quality colleagues, internal teams and external resources to act as a leader and educator in all aspects related to serialization.
Manage the design and implementation of business processes with Distribution and Warehouse operations, Packaging and CMOs to ensure unique identification of commercial product across the global supply chain.
Partner with the product traceability service provider to build system functionality and process design that meets business requirements.
Ensure packaging serialization processes meet regulatory and brand requirements while maintaining continuity of supply and building a platform that enables efficient onboarding in new regions.
Manage the serialization budget associated with providers, including licensing authorities and CMO set-ups.
Work with the global supply chain team and internal and external business counterparts to develop business process requirements that support regional regulatory requirements for Alexion RDU product traceability.
Develop project management plans that clearly articulate key dependencies and turning points, while identifying, communicating and managing risks and issues associated with the workstream.
Monitor international market requirements; initiate and coordinate actions to implement new requirements in line with regulatory directives.
Lead and run projects related to market-specific product presentation serialization requirements across Alexion internal sites and CMOs.
Configure and maintain master data and process integration with TraceLink, coordinating actions and root cause analysis for alert management notifications and regulatory intelligence processes.
Develop and maintain key metrics using monitoring and reporting tools for Product Alerts, providing status updates to the European Medicines Verification Organization.
Maintain strong relationships with external suppliers of serialization services as well as internal collaborators including Supply Chain, Equipment Engineering, Information Technology, QA Validation and Regulatory Affairs.
Oversee governance of the operational support model, including operational procedures that sustain compliant, reliable serialization and traceability operations.

Essential Skills/Experience

• Bachelor’s degree in Business, Information Systems or Project Management
• 8+ years proven track record in pharmaceutical/ biotech/ manufacturing Supply Chain environment.
• 6+ years serialization-related or product traceability experience and program management experience
• Knowledge of cGMP and associated CMC regulatory considerations in a pharmaceutical environment and global FMD requirements.
• Strong communication, collaboration, and team-building skills; ability to interact with all levels of the organization.

Desirable Skills/Experience

• Ability to influence both internal and external partners.
• Strong project management skills.
• Ability to lead multiple high-priority projects with a high degree of efficiency.

When we put unexpected teams in the same room, we unleash bold thinking with the power to
inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge
perceptions. That's why we work, on average, a minimum of three days per week from the office. But that
doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual
flexibility. Join us in our unique and ambitious world.

At AstraZeneca’s Rare Disease unit, work carries a direct line of sight to people living with rare and devastating conditions, turning complex serialization challenges into tangible impact on patients’ lives. The culture is patient-driven, energizing and kind, where diverse perspectives are valued, inclusion is championed and new ideas are encouraged from every corner of the business. Colleagues build strong connections across science, operations and commercial teams to explore better ways of working, innovate at pace and support each other through demanding but meaningful challenges. There is a strong commitment to personal growth through tailored development opportunities, alongside a shared pride in giving back to local communities and acting with integrity in everything we do.

Date Posted

09-Apr-2026

Closing Date

22-Apr-2026

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

Product Traceability & Serialisation Senior Manager-15427

Benefits

Job Description