Traceability Manager

Position Summary

The Product Traceability team is responsible for all activites associated with Product Traceability and Serialisation within Alexion AstraZeneca Rare Disease Unit (RDU). This is a business-critical role, as the decision maker holds overall accountability for Product Traceability and ensuring compliance to the market traceabiltiy requirements (examples EU, US, Russia, China).  You will be integral to ensuring product traceability systems, processes and standards are developed, implemented and tested while maintaining alignment with global standards and compliance regulations.

The role involves the day to day support of all Alexion product traceability and serialisation related activities.  This role will require cross functional collaboration within Alexion RDU Operations in all aspects of serialisation and product traceability as well as other AstraZeneca business units.  Operations includes, but are  not limited to, Packaing, QA, Warehouse & Distribution , Internal and External Manufacturing teams and Global Supply Chain Operations.

In addition to daily operations support , the role will include leading key business projects for product traceability and integration projects (onboarding of CMO’s, downstream partners and new markets).  Assume the role of subject matter expert within the area of serialisation and product traceability. Trouble shoot and support the business with respect to serialisation and associated processes.

Principal Responsibilities

• Responsible for the maintenance and and management of master data data within tracelink.
• Responsible for the various product traceability processes (alert management, release management, market regulatory compliance, security features)
• Responsible for the maintenance and management of all traceability SOP's across global operations.
• Conduct regular auditing of the process to ensure ongoing accuracy and compliance.
• Manage alerts that arise for the EU and oversee timely resolution.
• Work closely with the IT, packaging (internal and external) and Global Supply Chain and understand the effect of process and system changes on product traceability.
• Attend global team meetings.
• Participate in industry work groups on discussions relating to traceability market requirements.
• Define and deploy a serialization strategy for the Alexion RDU that is fully aligned to the Astra Zeneca strategy
• Represent Alexion RDU on the AZ Security Council and be responsible for rolling out security features across the Alexion business.

Qualifications

• 4+ years proven track record in pharmaceutical/biotech/manufacturing Supply Chain environment.
• 2+ years serialisation-related or product traceability experience.
• Possess a good knowledge of the pharmaceutical packaging process and the support functions of the supply chain (Artwork/Labelling, IT, Distribution etc).
• Ability to cope with fast-paced and dynamic business environment.
• Awareness of the regulatory landscape associated with serialisation  and product traceability (EU FMD, DSCSA).
• Understanding of packaging line processes and technology.

Competencies

• Project management experience
• Experience and knowledge of distribution processes preferably associated with product traceability.
• Computerised system and associated process ownership experience.
• Knowledge of cGMP and associated traceability regulatory considerations in a pharmaceutical environment.
• Strong communication and collaboration skills
• Ability to interact with all levels of the organisation.
• Ability to influence both internal and external partners.
• Detail-oriented with the ability to effectively manage multiple competing priorities.
• A team player who will actively contribute to process optimization discussions and to maintaining an inclusive work culture.
• Mental resilience, an ability to work under pressure and to navigate through ambiguity.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.