About the role
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 trackingOperational 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.
Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or a related field (advanced degree is a plus).Minimum 5 years of experience in pharmaceutical quality assurance, with a focus on supplier management.Hands-on experience in GMP environments and supplier auditing.Familiarity with QMS and supply chain operations.Strong organizational and planning skills.Ability to work independently and collaboratively in a dynamic environment.Commitment to quality, compliance, and continuous improvement.
