Vertex Pharmaceuticals
Quality Assurance , Vendor Management Specialist (27457) Contract
Vertex Pharmaceuticals, Boston, Massachusetts, us, 02298
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 Vertex 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. This role will 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 escalate 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. Ensure activities and deliverables are in compliance with FDA, EMA, SOPs and industry’s 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. In-depth strong knowledge of regulatory requirements in one or more GxP areas. Demonstrated experience with key performance indicators and quality metrics for vendors. Expertise in risk assessment as it pertains to third parties / suppliers. Demonstrated ability to communicate effectively, both orally and in writing. Mathematical acumen and excellent analytic skills as applied to risk assessments. Strong influencing skills and an innate ability to collaborate and build relationships. Pay Range
$45-$55/hr
possibility to come on as senior specialist $55+ No C2C or Third-Party Vendors
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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 escalate 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. Ensure activities and deliverables are in compliance with FDA, EMA, SOPs and industry’s 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. In-depth strong knowledge of regulatory requirements in one or more GxP areas. Demonstrated experience with key performance indicators and quality metrics for vendors. Expertise in risk assessment as it pertains to third parties / suppliers. Demonstrated ability to communicate effectively, both orally and in writing. Mathematical acumen and excellent analytic skills as applied to risk assessments. Strong influencing skills and an innate ability to collaborate and build relationships. Pay Range
$45-$55/hr
possibility to come on as senior specialist $55+ No C2C or Third-Party Vendors
#J-18808-Ljbffr