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Job description
Base pay range
$55.00/hr - $65.00/hr
General/Position Summary
The Vendor Quality Management Specialist is responsible for the onboarding and assessment of vendor risks in one or more GxP areas and drives the completion of vendor qualification requirements that allow the company to demonstrate appropriate oversight of our third parties. The role contributes to the advancement of vendor management processes and tools that are fit-for-purpose across assigned GxP area and vendor types. The role will closely partner with Material Management, Manufacturing, Analytical/Process Development, and Quality Control stakeholders to meet business, regulatory and operational requirements and support vendor metrics monitoring, risk mitigations and inspection readiness.
Key Duties & Responsibilities
Oversee onboarding of new vendors, including initiation vendor setup requests, GMP risk assessment, and documentation collection.
Support qualification activities through review of vendor submissions, evaluation of GMP capabilities, and alignment on vendor criticality and approval status.
Lead and drive end-to-end Quality Agreement lifecycle: drafting, coordinating cross-functional review, managing vendor negotiations, and ensuring timely execution.
Collaborate with Procurement, Technical Operations, and Supply Chain to ensure all readiness steps are completed.
Maintain up-to-date vendor risk profiles and qualification status in vendor management system.
Establish and maintain the Quality Agreement tracker and elevate delays, risks, or gaps in coverage to QA leadership.
Support and process supplier corrective action reports (SCARs) and Vendor Change Notifications (VCNs). Support VQM related Deviations, CAPAs, and Change Controls as appropriate.
Ensure agreements reflect internal standards, regulatory expectations, and program-specific requirements (e.g., commercial readiness, BLA activities).
Ensure vendor management procedures, SOPs, and templates remain current and reflect evolving practices.
Lead/participate in Cell & Genetic Program Quality & technical projects and drive continuous improvement activities as assigned by Management, ensuring compliance with FDA, EMA, SOPs and industry best practices.
Required Education Level
Bachelor's degree in a scientific or allied health field
Master's degree or relevant comparable background
Required Experience
Typically requires >5 years of relevant industry experience such as vendor management, supply chain, quality assurance and/or manufacturing in biotechnology/regulated pharmaceutical environment.
Required Knowledge/Skills
In-depth strong knowledge of regulatory requirements in one or more GxP areas
Demonstrated
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Worksite address
boston, MA, 02298, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.