This is what you will do:This position operates within the Supplier Quality team to support the qualification and monitoring of GxP Suppliers with a specific focus on Supplier Seelction and Qualification.
The Supplier Quality team operates globally across Alexion and sits within the wider Central Quality Systems and Compliance department.
Support the Supplier Qualificatin processes ensuring suppliers are qualified to Alexion and Regulatory standards.Develop and manage a Supplier Oversight Governance process across Alexion operations.Manage and Oversee the Supplier Management Periodic Review process, including preparation of data for the review, summarizing the results and status to drive quality improvement opportunities within the supply chain.Support the management of the Global Supplier Quality program for Alexion operations.
Manage all Supplier Quality inputs including quality agreements, questionnaires, audits, change control, etc.Own training programs for Supplier Quality processesDevelop and maintain strong relationships with internal and external stakeholders to ensure optimal performance.You will be responsible for:Managing the Supplier Qualification Processes and systemsManaging the Quality Agreement processDelivering a robust training program for Supplier Quality processes and systemsIdentify process compliance gaps and develop/implement plans to resolve issues and mitigate quality risks.Establish and track quality metrics for internal processes and identify and implement improvement opportunities.Support audits and inspections, as appropriate.Perform all responsibilities in accordance with company policies, procedures, federal regulations and safety requirements.You will need to have:Experience with Quality Risk Management and Structured Problem-Solving toolsExperience supporting regulatory inspectionsA strong customer focus and ability to prioritize and adapt to business needs are requiredKnowledge of applicable international GXP regulations and standardsStrong leadership, negotiation, collaboration and influence skills in a matrix organizationDemonstrated project management skills; experience leading cross-functional teams, and decision making with a focus on delivering results.Excellent communication skillsStrong ability to analyze systems, dataThe duties of this role are generally conducted in an office environment.
As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have:M.Sc.
or equivalent in Biological Sciences, Chemistry, Microbiology or other science.Minimum of 6+ years' experience in Quality with biologics, pharmaceutical, or medical deviceExperience working with mature supplier quality systemPrevious global Quality System development/deployment experienceDate Posted11-Jul-2024Closing Date29-Sep-2024Our 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.