Location : Barcelona
Introduction to role : Join us at AstraZeneca as a Systems Manager in our Logistics and Clinical Supply (LCS) team. In this role, you will plan and lead supply systems activities to enable IMP manufacture and supply to AZ clinical trials. This is an opportunity to improve the use of the organisation's resources and meet agreed requirements, timelines and quality standards.
Accountabilities :
Independently plans and leads assigned LCS Systems activities. Provides systems administration for the SmartSupplies Suite, and delivers Interactive Response Technology (IRT) development and User Acceptance Testing (UAT) as relates to assigned clinical programs, ensuring to meet customer demands in a manner that is aligned with standards and regulations, minimizes costs and improves quality.
Supports and enables a small team of multi-functional professionals to deliver the supply chain strategy through LCS systems in good alignment with the clinical development plan and overall program goals.
Supports change initiatives, partnering with stakeholder groups to gather relevant information that can be used to see opportunities for improving the efficiency of the supply systems strategy.
Support internal and external communications to enable existing infrastructures and collaborate with SmartSupplies.
Supports timely maintenance of current, accurate and complete IMP Systems records, ensuring that vital information is filed to all relevant GXP repositories including Product Specification File (PSF) and Trial Master File (TMF).
Builds, or assists in the creation of departmental SOPs, processes, and tools to support improvement and future growth of LCS and Systems Management standard methodology.
Employs experience and expertise in supply chain systems management to resolve issues and problems before they redefine program supply.
At a functional level, applies skills and knowledge to enable improved working practices in relation to robust clinical supply systems functionality, utilisation and reporting.
Collects and analyses metrics on supply systems capabilities and compares this to goals and objectives set for the function to assist more senior leaders in developing an understanding of challenges and opportunities ahead.
Ensures systems and procedures are in place to assure the day-to-day functioning of the supply chain. Trains, develops and supports other staff (LCS flex roles / rotational placements etc) to function efficiently within the Systems Management team.
Works collaboratively within LCS and with QA, Clinical, IT, project teams and all other interfaces and partners as required.
Contributes to the operational efficiency of LCS.
Essential Skills/Experience :
Extensive knowledge of supply chain management techniques
Experience working with ERP or comparable supply chain systems
Highly organized individual who possesses excellent attention to detail, and demonstrates strong skills for planning, coordination, collaboration, and communication
Desirable Skills/Experience :
Proven success in delivery of cross-functional projects and/or activities
Ability to re-engineer processes
An understanding of IRT and clinical supply strategies
Proven understanding of cGMP, GCP and ICH guidelines as relates to IMP labelling, packaging and distribution
Proven understanding of 21CFR Part 11 compliance
A sound understanding of the supply chain process and good understanding of Clinical Trial Management (CTM) system capabilities and deployment to enable system design, implementation, training and ongoing super-user support
General understanding of integration requirements between SmartSupplies suite of products, IRT, eCTMS, Veeva Vault, RAVE, Business Objects, SharePoint and Microsoft Suite.
Development of reports using SAP Business Objects or similar system
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