Senior Specialist, Supplier Quality
2 days ago
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 and material approval processes including migration of site-based processes to the global process.
- Support Supplier Change Notification process to ensure appropriate change control and regulatory updates have been made prior to making changes.
- Manage monitoring of approved Suppliers and materials through data gathering and reporting.
- Support management of all new materials for qualification requests.
- Chair Materials Review Board (multi-functional teams across Alexion operations) and monitor progress of materials qualification from start to finish.
- Support build of material qualification packs and updates initiated via Supplier Change Notifications.
- Support periodic review of approved Suppliers.
- Gather data and report quality metrics for internal processes and identify and implement improvement opportunities.
- Manage Continuous Improvement of the Supplier Quality System and Material Introduction and Qualification procedure.
- Manage any project work related to Supplier Quality.
- Point of contact for audits and inspections, as appropriate. Manage deviations and change controls related to supplier and material qualification activities.
- Perform all responsibilities in accordance with company policies, procedures, federal regulations and safety requirements.
- Represent Supplier Quality at internal meetings.
- Provide project support and management to cross-functional multi-skilled teams.
- Offer first-line support and end-user training (development and delivery) for Material Qualification program.
- Collaborate with others to define initiatives to improve material qualification performance that will deliver business benefits in a compliant manner.
- Maintain and manage supplier/materials data in management systems e.g. SAP and Veeva.
You will need to have:
- Minimum of 4+ years’ experience working in a GMP environment with experience in Material Qualification, Procurement, Quality Assurance, or Auditing.
- 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 and 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 a wide range of perspectives, 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.
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Dublin, Ireland AstraZeneca GmbH Full timeThis 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...
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