Senior Specialist External Quality

AstraZeneca • Gaithersburg, MD

2d

About The Position

The Senior Specialist External Quality will be responsible for managing and improving the supplier quality management system. This role involves ensuring audit compliance, managing supplier audit reports and corrective actions, developing performance metrics, and contributing to the continuous improvement of supplier quality processes. The position also supports internal and external audits, oversees SAP QM module implementation, manages supplier-related changes, tracks supplier quality trends, and communicates quality and regulatory issues to management. Additionally, the role assists in developing the Approved Supplier List and identifying best practices in supplier qualification and management.

Requirements

• Bachelor's Degree in Biology, Biochemistry, Chemistry, Engineering or related fields
• 1+ years of supplier quality experience
• 7+ years of Quality experience
• Computer Skills: MS Outlook, MS Powerpoint, MS Excel, MS Word

Nice To Haves

• Drug Substance and/or Drug Product experience
• Autologous, Allogenic, or In-vivo cell therapy experience
• Graduate degree in related field

Responsibilities

• Ensure audit due dates for suppliers are maintained.
• Manage and provide guidance and/or assist in defining, implementing and follow-up for supplier audit reports and CAPA ensuring adequate corrective action is in place and monitoring the effectiveness of that action.
• Development of a Supplier Quality management performance evaluation through Key Performance Indicators (KPI) and continuous improvement for the highest effectiveness of the supplier management system.
• Contribute to the development, maintenance and improvements of supplier management policies, standards and procedures.
• Participate in supplier development projects and continuous improvement activities focusing on supplier quality.
• Assist in Internal audits and ISO/FDA audits.
• Responsible for SAP Quality Module implementation (QM Views, inspection plans, AMPL).
• Responsible for overseeing Supplier related changes and implementation of required actions to address changes.
• Responsible for tracking Supplier quality on a monthly / quarterly basis, identify supplier non-conformance trends and implement appropriate supplier actions.
• Communicate to management quality and regulatory issues on a timely basis.
• Assist with development of the Approved Supplier List and areas to be targeted during the assessment or evaluation.
• Identify and leverage best practices across supplier qualification, surveillance, process and quality management system audits.

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior