Supplier Qualification Specialist

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.