Global Supplier Quality System Professional

Global Supplier Quality Professional

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

Global Supplier Quality Professional is responsible for leading and executing the global Supplier Change Management, Vendor Change Notification (VCN), and Supplier Quality Agreement (SQA) programs, ensuring that supplier-initiated changes to materials, components, processes, facilities, equipment, sourcing, quality systems, and contractual quality requirements are identified, assessed, approved, communicated, and implemented in compliance with regulatory, quality, and business requirements.

This role serves as the primary liaison between suppliers and cross-functional stakeholders, including Quality, R&D, Operations, Legal, and Procurement, to evaluate the impact of supplier changes on product quality, patient safety, regulatory compliance, and supply continuity. The position drives robust change notification and supplier quality governance processes by establishing, negotiating, implementing, and maintaining Supplier Quality Agreements that clearly define quality responsibilities, change notification requirements, compliance expectations, and escalation pathways between the organization and its suppliers.

The role monitors supplier compliance with change notification requirements and Supplier Quality Agreements through performance metrics.

Key Responsibilities

Vendor Change Management, Quality Agreement Governance & Compliance

• Lead and execute the global Vendor Change Notification (VCN), Supplier Change Management, and Supplier Quality Agreement (SQA) programs.
• Ensure supplier-initiated changes (e.g., material, component, process, equipment, facility, subcontractor, test method, and quality system changes) are identified, reviewed, approved, and implemented in accordance with Quality Management System (QMS) requirements, Supplier Quality Agreements, and regulatory expectations.
• Develop, negotiate, implement, maintain, and periodically review Supplier Quality Agreements to ensure clear definition of quality responsibilities, change notification requirements, regulatory compliance obligations, escalation processes, record retention requirements, and supplier performance expectations.
• Maintain and continuously improve supplier change management and Supplier Quality Agreement procedures, policies, templates, and governance processes to ensure consistency, compliance, and effectiveness across the supplier network.
• Establish supplier change notification requirements, risk classifications, approval workflows, and escalation pathways, ensuring alignment with Supplier Quality Agreement commitments and business requirements.
• Monitor supplier compliance with contractual quality obligations and change notification requirements, ensuring timely communication and adherence to agreed quality standards.

Supplier Change Assessment & Lifecycle Management

• Evaluate supplier change notifications for potential impact to product quality, patient safety, regulatory compliance, manufacturing processes, and supply continuity.
• Coordinate cross-functional reviews involving Quality, R&D, Engineering, Operations, and Procurement to assess, approve, and implement supplier changes.
• Review supplier changes against Supplier Quality Agreement requirements to ensure all notification, approval, and compliance obligations are fulfilled.
• Maintain supplier change records and ensure traceability throughout the change lifecycle.

Supplier Quality Agreement Management

• Serve as the business owner and subject matter expert for the Supplier Quality Agreement program.
• Partner with Procurement, Legal, Regulatory Affairs, and Quality teams to negotiate, execute, renew, and maintain Supplier Quality Agreements across the supplier lifecycle.
• Ensure Supplier Quality Agreements are established for applicable suppliers based on risk, regulatory requirements, and business needs.
• Conduct periodic reviews of Supplier Quality Agreements to ensure alignment with current regulatory requirements, quality system expectations, organizational policies, and supplier capabilities.
• Drive resolution of quality agreement gaps, deviations from contractual requirements, and compliance concerns through collaboration with suppliers and internal stakeholders.
• Maintain Supplier Quality Agreement documentation, records, metrics, and governance processes to support audit readiness and inspection preparedness.

Supplier Performance Monitoring & Continuous Improvement

• Monitor supplier compliance with change notification requirements and Supplier Quality Agreement obligations, including timeliness, completeness, and effectiveness.
• Track key performance indicators (KPIs) related to supplier change management, and quality agreement compliance.
• Analyze trends in supplier changes, audit observations, quality events, and contractual compliance metrics to identify emerging risks and improvement opportunities.
• Drive continuous improvement…