Position Summary

The Product Traceability team is responsible for all activities related to product traceability and serialization within the Alexion AstraZeneca Rare Disease Unit (RDU). This is a business-critical role, as the decision-maker holds overall accountability for product traceability and for ensuring compliance with market traceability requirements (e.g., EU, US, Russia, China). You will be integral to developing, implementing, and testing product traceability systems, processes, and standards while maintaining alignment with global standards and regulatory compliance.

The role involves day-to-day support of all Alexion product traceability and serialization activities. It requires cross-functional collaboration within Alexion RDU Operations across all aspects of serialization and product traceability, as well as coordination with other AstraZeneca business units. Operations include, but are not limited to, Packaging, Quality Assurance (QA), Warehouse and Distribution, Internal and External Manufacturing, and Global Supply Chain Operations.

In addition to daily operational support, the role includes leading key business initiatives for product traceability and integration projects (e.g., onboarding CMOs, downstream partners, and new markets). You will serve as the subject matter expert in serialization and product traceability, troubleshooting issues and supporting the business on serialization and associated processes.

Principal Responsibilities

· Master Data Management: Maintain and manage master data within TraceLink, ensuring accuracy, completeness, and timely updates.

· Traceability Processes: Own end-to-end product traceability processes, including alert management, release management, market regulatory compliance, and security features.

· SOP Governance: Maintain and manage all traceability SOPs across Global Operations, ensuring alignment with AstraZeneca standards and periodic review cycles.

· Auditing and Compliance: Conduct regular audits of traceability processes to confirm ongoing accuracy, data integrity, and compliance with market requirements.

· EU Alert Resolution: Monitor and manage EU alerts, driving timely investigation, remediation, and closure, with appropriate documentation.

· Cross-Functional Collaboration: Partner closely with IT, Packaging (internal and external), and Global Supply Chain to assess and manage the impact of process and system changes on product traceability.

· Brand Launch Representation: Represent Alexion in brand launch project meetings, ensuring serialization and traceability readiness for new products and markets.

· Industry Engagement: Participate in industry working groups on traceability market requirements and bring insights back to influence internal strategy and compliance.

· Serialization Strategy: Define and deploy a serialization strategy for the Alexion RDU that is fully aligned with the broader AstraZeneca strategy, including roadmap, governance, and performance metrics.

· Security Features and Governance: Represent Alexion RDU on the AZ Security Council and lead the rollout of security features across the Alexion business, ensuring effective change management and adoption.

Qualifications

· Industry Experience: 4+ years of demonstrated experience in a pharmaceutical/biotech/manufacturing supply chain environment.

· Serialization/Traceability: 2+ years of hands-on experience in serialization and/or product traceability.

· Packaging and Supply Chain Knowledge: Strong understanding of pharmaceutical packaging processes and supporting supply chain functions (e.g., artwork/labeling, IT, distribution).

· Adaptability: Proven ability to operate effectively in a fast-paced, dynamic business environment.

·Regulatory Awareness: Working knowledge of the regulatory landscape for serialization and product traceability (e.g., EU FMD, DSCSA).

· Packaging Line Technology: Understanding of packaging line processes and associated technologies.

Competencies

· Project Management: Experience planning, executing, and delivering cross-functional projects, with clear ownership of scope, timeline, and risks.

· Distribution and Traceability: Knowledge of distribution processes, preferably with direct exposure to product traceability workflows and systems.

· Systems and Process Ownership: Experience owning computerized systems and associated business processes, including change control and user support.

· Quality and Compliance: Knowledge of cGMP and traceability-related regulatory considerations in a pharmaceutical environment.

· Communication and Collaboration: Strong written and verbal communication skills; ability to collaborate effectively across functions and regions.

· Stakeholder Engagement: Ability to interact with all levels of the organization and influence internal and external partners.

· Prioritization and Detail Orientation: Detail-oriented with the ability to manage multiple, competing priorities and meet deadlines.

· Team Contribution: A collaborative team player who contributes to process optimization and supports an inclusive work culture.

Date Posted

10-Mar-2026

Closing Date

24-Mar-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.

Senior Manager Traceability

Job Description