Supplier Quality Manager

Essential Duties and Responsibilities

Supplier Qualification and Lifecycle Management

• Own and administer the GxP supplier and vendor qualification program in accordance with applicable procedures and regulatory requirements.
• Lead the risk-based assessment, qualification, approval, monitoring, requalification, and disqualification of suppliers.
• Review and approve supplier qualification questionnaires and supporting documentation.
• Assess supplier quality systems, technical capabilities, compliance history, and potential risk to product quality, patient safety, data integrity, and regulatory compliance.
• Establish qualification requirements based on supplier type, criticality, intended use, and GxP risk.
• Ensure qualification decisions and supporting documentation are complete, traceable, and inspection ready.
• Maintain supplier qualification status and applicable records in the electronic Quality Management System, including the Approved Vendor List.

Supplier Audits

• Support the development and maintenance of a risk-based supplier audit program and audit schedule.
• Support planning, conducting, and documenting on-site, remote, and qualification audits of GxP suppliers and service providers.
• Support regulatory inspections and partner audits involving supplier oversight.

Supplier Quality Agreements

• Lead the preparation, review, negotiation, approval, maintenance, and periodic review of GxP Quality Agreements.
• Ensure Quality Agreements clearly define responsibilities for deviations, investigations, CAPAs, change notification, complaints, data integrity, records, audits, subcontracting, regulatory inspections, and other applicable quality requirements.
• Partner with Legal, Supply Chain, CMC, Manufacturing, Clinical, IT, and other functions to establish appropriate provisions.
• Monitor supplier compliance with established Quality Agreement requirements.

Supplier Performance Management

• Develop and maintain a risk-based supplier performance monitoring and scorecard program.
• Establish meaningful KPIs and quality metrics for critical suppliers.
• Monitor performance across SCARs, audit findings, deviations and quality events, CAPA effectiveness, change notifications, responsiveness, recurring issues, delivery of quality commitments, and compliance with Quality Agreements.
• Conduct periodic supplier performance reviews and communicate trends, risks, and recommendations to Quality leadership and cross-functional stakeholders.
• Identify suppliers requiring enhanced oversight or formal improvement plans.
• Present supplier quality trends and significant risks during Quality Management Review and other governance forums.

Supplier Corrective Action and Escalation

• Lead or coordinate Supplier Corrective Action Requests for significant supplier quality issues.
• Ensure appropriate containment, investigation, root cause analysis, corrective and preventive actions, and effectiveness verification.
• Assess supplier investigation and CAPA responses for scientific and technical adequacy.
• Identify recurring issues and escalate significant quality, compliance, supply continuity, or patient-risk concerns.
• Facilitate cross-functional supplier quality escalation meetings, as necessary.
• Partner with suppliers to drive sustainable improvement rather than relying solely on correction or retraining.

Quality Systems and Compliance

• Ensure supplier quality activities are conducted in accordance with applicable GxP requirements, company procedures, and Quality Agreements.
• Integrate Supplier Quality with deviations, CAPA, change control, document control, training, Quality Management Review, and other QMS processes.
• Evaluate supplier-related changes for potential impact to product quality, process performance, validated state, regulatory commitments, and supply continuity.
• Develop and revise Supplier Quality procedures, forms, templates, risk-assessment tools, metrics, and training materials.
• Maintain supplier quality records in an inspection-ready state.
• Support internal audits, partner audits, due diligence activities, and regulatory inspections involving supplier oversight.

Data Integrity and Computerized-System Supplier Oversight

• Ensure qualification of GxP software, SaaS, cloud, and computerized-system suppliers appropriately evaluates validation and data-integrity controls.
• Assess supplier practices related to system validation, audit trails, user-access management, electronic records, backup and recovery, subcontractors, and change notification, as applicable.
• Ensure supplier assessments address relevant data integrity expectations and appropriate controls for technologies supporting GxP activities.
• Partner with Quality Systems, IT, system owners, and validation stakeholders when qualifying computerized systems and technology suppliers.