The Supply Chain Quality Manager supports supply chain continuity across multiple sites, with a strong focus on supplier quality oversight, vendor change notifications, change controls, CAPAs, deviations, and material lifecycle management within a cGMP environment. This role partners closely with Quality Assurance, Supplier Quality, Manufacturing, Strategic Sourcing, and external suppliers to ensure purchased materials and services meet quality, regulatory, delivery, and business requirements.
Represent Supply Chain on cross-functional project teams, quality forums, task forces, and supplier-related initiatives.
Review, assess, coordinate, and track vendor change notifications to determine potential impact on materials, specifications, manufacturing processes, regulatory filings, quality systems, supply continuity, and inventory.
Partner with Quality Assurance and Supplier Quality to initiate, support, and close change controls, including impact assessments, implementation plans, required documentation, and effectiveness checks.
Support investigations for supplier-related deviations, nonconforming materials, complaints, and supply disruptions by gathering purchasing, delivery, supplier, and material history data.
Participate in and support Corrective and Preventive Actions (CAPAs) associated with suppliers, materials, purchasing processes, and supply chain quality risks.
Ensure supplier notifications, change controls, deviations, CAPAs, and related actions are tracked to completion within required timelines.
Drive supplier and material onboarding activities, including approved vendor setup, material specifications, quality documentation, and master-data requests.
Monitor purchase orders throughout their lifecycle and communicate risks related to quality, delivery, documentation, capacity, lead time, or supplier performance.
Collaborate with suppliers and internal stakeholders to resolve quality, delivery, financial, documentation, and compliance issues.
Coordinate the disposition of nonconforming materials with Quality, Manufacturing, Warehouse, and suppliers to minimize operational impact.
Maintain supplier performance metrics for quality, delivery, responsiveness, service, and compliance; identify trends and escalate emerging risks.
Compile, analyze, and present supplier performance data to support supplier evaluations, quality reviews, contract compliance, and supplier development plans.
Support supplier risk assessments, supplier qualification activities, and periodic supplier performance reviews.
Maintain accurate purchasing and supplier master data, including approved vendor status, lead times, pricing, material attributes, quality requirements, and supplier documentation.
Contribute to the development and continuous improvement of purchasing, supplier quality, material control, and standard-work processes.
Build strong cross-functional relationships with Quality, Manufacturing, Planning, Finance, Warehouse, Regulatory, and external suppliers.
Independently prioritize urgent operational needs while advancing continuous-improvement and quality-system commitments.
Perform other duties as assigned.
Strong understanding of cGMP supply chain operations, supplier quality management, and material controls within pharmaceutical, biotechnology, or medical-device environments.
Experience reviewing and assessing vendor change notifications, including potential impacts on materials, specifications, processes, documentation, and supply continuity.
Working knowledge of quality management systems, including change controls, deviations, nonconformance investigations, CAPAs, root-cause analysis, and effectiveness checks.
Ability to analyze supplier-related quality trends, investigate issues, and develop practical risk-mitigation actions.
Knowledge of supplier qualification, approved supplier lists, supplier performance management, and quality agreements preferred.
Proven ability to manage multiple projects, priorities, and time-sensitive deliverables effectively.
Strong written and verbal communication skills, with the ability to communicate across all organizational levels and with external suppliers.
Ability to interpret material specifications, supplier documentation, certificates of analysis, change notifications, and quality records.
Demonstrated ability to work independently, exercise sound judgment, and escalate quality or supply risks appropriately.
Strong analytical, problem-solving, organizational, and stakeholder-management skills.
Experience with ERP, iProcurement, purchasing, document-management, and quality-management systems.
Experience in pharmaceutical, biotechnology, medical-device, or other regulated manufacturing environments.
Experience working in a fast-paced or startup environment preferred.
Bachelor's degree in Supply Chain, Manufacturing Operations, Quality, Engineering, Life Sciences, Business, or a related discipline.
3–5 years of relevant experience in supply chain, supplier quality, or quality operations within a regulated industry.
Experience supporting quality systems activities, including vendor change notifications, change controls, deviations, investigations, and/or CAPAs preferred.
A certificate or associate degree with 10+ years of relevant experience may be considered in lieu of a bachelor's degree.
| Location | Boston, MA |
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