Senior Specialist Supplier Quality - Permanent

Alexion Pharmaceuticals

Dublin
Permanent
Full-time

1 month ago

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 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, 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..
Support Supplier Change Notification process to ensure appropriate change control and regulatory updates have been made prior to making changes.
Perform monitoring of approved Suppliers through data gathering and reporting.
Perform periodic review of approved Suppliers.
Gather data and report quality metrics for internal processes and identify and implement improvement opportunities.
Lead Continuous Improvement projects for Supplier Quality System
Develop and deliver SQ Process Training
Act as Supplier Quality SME for audits and inspections.
Perform all responsibilities in accordance with company policies, procedures, federal regulations and safety requirements.

You will need to have:

Minimum of 6+ years' experience working in a GMP environment with experience in Supplier Qualification and Oversight including authoring Quality Agreements.
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 analyse 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 inspectionsAstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.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.

Alexion Pharmaceuticals

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