This is what you will do:
This position operates within the Supplier Quality team to support the selection, qualification and post-qualification monitoring of GxP Suppliers with a focus on Material Qualification. The Supplier Quality team operates globally across Alexion and sits within the wider Central Quality Systems and Compliance department.
* Act as a SME for Alexion operations Material Qualification program.
* Develop and Manage a single Material Qualification process across Alexion operations.
* Support the management of the Global Supplier Quality program for Alexion operations.
* Manage all Supplier Quality inputs including quality agreements, material qualification packs, questionnaires, audits, change control, etc.
* Oversight of Material Review Board and other cross functional team meetings via matrix management.
* Support 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.
* Develop and maintain positive relationships with internal and external stakeholders to ensure efficient performance.
You will be responsible for:
* Support the global Material Qualification processes and transition existing site-based processes to global processes.
* Lead a team to administer the Material Qualification program.
* Mentor the Materials Qualification team.
* Identify process compliance gaps and develop/implement plans to resolve issues and mitigate quality risks, escalations to Leadership Team.
* 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:
* B.A. / B.Sc. or equivalent in Biological Sciences, Chemistry, Microbiology or other science.
* Minimum of 6+ years’ experience in Quality with medical device, pharmaceutical, or biologics experience.
* Experience in Supplier and Material Qualification required.
* Experience with Quality Risk Management and Structured Problem-Solving tools required.
* A strong customer focus and ability to prioritize and adapt to business needs are required.
We would prefer for you to have:
* Experience working with mature supplier quality system.
* Previous global Quality System development/deployment experience.
* Experience supporting regulatory inspections.
* Knowledge of applicable international GXP regulations and standards.
* Strong leadership, negotiation, collaboration and influence skills in a matrix organization.
* Demonstrated project management skills; experience leading cross-functional teams, and decision making.
* Strong business partner with a focus on delivering results.
* Excellent communication skills.
* Strong ability to analyze systems, data.
* Capable of identifying and mitigating risks.
* Experience with high performance teams, cross functional projects.
* Project management certification and/or experience is beneficial.
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