Kindeva Drug Delivery

Supplier Quality

• Execute global supplier quality strategies, policies, and procedures across regions and business units.
• Ensure supplier quality processes align with QMS requirements and regulatory standards.
• Partner with Global Supply Chain and Procurement on supplier segmentation, risk classification, and oversight models.
• Assist with supplier selection, qualification, onboarding, and inclusion in Approved Supplier Lists.
• Conduct and/or lead supplier audits, including initial, surveillance, and for-cause audits.
• Maintain supplier quality agreements, specifications, and performance expectations.
• Monitor supplier performance metrics such as defect rates, on-time delivery, and cost of poor quality.
• Identify performance trends and drive continuous improvement initiatives with suppliers.
• Execute supplier development programs to improve process capability, reduce variability, and enhance product quality.
• Represent Global Supplier Quality in root cause investigations and resolve supplier quality issues using structured methodologies such as 8D and DMAIC.
• Drive Supplier Corrective and Preventive Actions (SCAR/CAPA) and verify effectiveness.
• Execute non-conformance, deviation, and escalation processes across the global supply base.
• Ensure supplier controls meet applicable ISO 13485, FDA, and GMP requirements.
• Support internal and external audits, inspections, and regulatory submissions related to supplier quality.
• Maintain audit readiness through documentation, traceability, and quality records.
• Partner with R&D, Engineering, and Operations on new product development and supplier integration.
• Provide supplier quality input into design controls, risk management, and validation activities.
• Work cross-functionally with internal stakeholders and global suppliers.
• Mentor junior supplier quality professionals and provide technical guidance.
• Assist in cross-functional and cross-regional initiatives to drive harmonization and best practices.
• Influence decision-making through data-driven insights and supplier performance analytics.

Senior Global Supplier Quality Professional