Supply Chain Lead
hace 2 días
Macclesfield
Role - Clinical Supply Study Lead Duration - 12 months Location - Macclesfield, UK (3 days per week on-site) Outside IR35 Role Overview The Clinical Supply Study Lead (CSSL) designs and executes supply chain for one or more global clinical studies across all phases within drug development. The CSSL holds overall accountability for delivery of IP and co-ordinates associated tasks and activities across all relevant functions within the supply chain. The Role will have multiple contacts across internal and external groups including leadership of working groups. Stakeholder management: • Lead the Study Drug Working Group to enable continuous dialogue with the clinical team on the study design requirements and their changes affecting supply chain of the study., • Lead/contribute to Kick Off Meetings for relevant suppliers (i.e. PLD, clinical CRO, IRT) and maintain collaboration throughout the study lifecycle., • Escalation of risks / issues / concerns relating to systems and activities through appropriate channels, • Support knowledge sharing and creating great place to work environment among peers across whole Global Clinical Supply Chain Demand and Supply - planning and management: • Development/input to key documents reflecting supply chain design & requirements: CAA (or equivalent), SDPA, PSF, • Refined initial and continuous study demand forecasting in order to create a Supply Plan for primary and secondary packing, together with identification of risks relatedto demand/supply., • Demand and supply efficient change management., • Inventory management. Cost management: • Assessment of projected costs related to packaging, labellingand distribution In line with SAMPA process., • Control of ongoing study spend via PO and invoice approval., • Flagging risks related to budget constraints via SCT Compliance: • Management of Quality Events (i.e. Deviations, CAPAs, Complaints, Change Control), • Provide regular update during Visual Management meetings according to SCQS (SHE, cost, quality, supply) priorities, • Ensuring eTMF compliance, • OOD reporting Packing/labelling/distribution activities • Definition and implementation of PLD strategy, • Implementation of TCM and management of the strategy, • Master Label development (if relevant), • Destruction management, • Expiry date management, • Extension of shelf life, • Rework & recalls Essential Requirements: Knowledge of Clinical Supply chain and drug development process. Awareness of GXP Standards within a Clinical environment Demand planning and forecasting experience Experience of managing a study / project and influencing customer demands. Internal & external stakeholders Proficient IT skills with an ability to adapt and operate in multiple systems We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. 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.