Specialist – Supplier Quality (FTC)

This role is a 12 month fixed term contract

This is what you will do:

Within the Supplier Quality team, you’ll become part of a team of professionals working with all aspects of the Alexion business from development to commercialization and distribution.  You will support the management of the Supplier Quality program with focus on Materials Qualification for all of Alexion. Assist in the Supplier and Material approval process and in the management of all Supplier Quality inputs including quality agreements, questionnaires, audits, supplier corrective action reports, supplier change notifications, materials qualification packs, Alexion change control, etc.  Assist in the preparation of inputs to the Supplier Management Review process, including preparation of data for the review.  Assist in the monitoring and reporting of supplier performance indicators and contribute to the quality improvement opportunities within the supply chain.

You will be responsible for:

• Support the global supplier qualification and oversight processes including migration to Enterprise systems..
• Maintain supplier data in management systems e.g. SAP and Veeva
• Support monitoring of approved Suppliers through data gathering and reporting.
• Support periodic review of approved Suppliers.
• Gather data and report quality metrics for internal processes and identify and implement improvement opportunities.
• Support implementation of Continuous Improvements for supplier and/or material qualification and Supplier Quality Systems.
• material qualification and Supplier Quality System
• Deliver SQ Process Trainingg
• Provide project support work related to SQ and to cross-functional multi-skilled teams, as required.
• Support build of material qualification packs and updates initiated via Supplier Change Notifications.
• Support audits and inspections.
• Perform all responsibilities in accordance with company policies, procedures, federal regulations and safety requirements.

You will need to have:

• Minimum of 3+ years’ experience working in a GMP environment with experience in Quality Assurance.
• Experience with Quality Risk Management and Structured Problem-Solving tools
• A strong customer focus and ability to prioritize and adapt to business needs
• Knowledge of applicable international GXP regulations and standards
• Strong business partner with a focus on delivering results.
• Excellent written and verbal communication skills
• Strong ability to analyze systems and data
• Capable of identifying and mitigating risks
• Experience with high performance teams, cross functional projects.

We would prefer for you to have:

• Experience with Technical Writing
• Experience working with mature supplier quality system
• Previous global Quality System development/deployment experience
• Experience supporting regulatory inspections

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.