Role Description: As a Supplier Qualification Specialist, you will play a key role in ensuring the quality, compliance, and regulatory integrity of external suppliers and contract manufacturing organizations (CMOs). You will support supplier-related quality assurance activities, ensuring alignment with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and applicable regulatory standards.   Key Responsibilities: Supplier Quality Support: • Execute supplier qualification and performance monitoring activities. • Support the implementation of supplier quality strategies in collaboration with procurement and supply chain teams. • Ensure documentation and processes meet internal and external compliance standards. • Update approved supplier list, handling supplier changes, CAPAs and using Helix (eQMS) for tracking Operational Quality Activities: • Maintain supplier quality management systems in line with company and regulatory requirements. • Monitor supplier KPIs and support continuous improvement initiatives. • Participate in investigations related to supplier deviations, complaints, and non-conformities. Audits and Qualification: • Assist in planning and conducting supplier audits. • Follow up on audit findings and ensure timely completion of corrective and preventive actions (CAPAs). • Contribute to the assessment and onboarding of new suppliers. Compliance and Risk Mitigation: • Identify potential risks in supplier quality and escalate issues as needed. • Ensure adherence to global regulatory requirements (FDA, EMA, MHRA, WHO, etc.). Cross-Functional Collaboration: • Act as a quality liaison with suppliers, procurement, and supply chain teams. • Provide quality input during supplier selection and due diligence processes. • Participate in internal quality forums and working groups as required.