Position Details Job Title Specialist GxP Supplier Qualification Department Global QA Reports To Global Director, Vaccine Quality Assurance Essential Roles and Responsibilities • Act as the global QA SME for qualification and oversight of GxP-relevant suppliers, including GMP, GLP, GCP, GDP etc., service providers.
• Lead the development, implementation, and continuous improvement of the supplier qualification program, including risk-based classification, audit planning, and ongoing performance monitoring.
• Conduct supplier audits (initial, routine, for-cause), prepare audit reports, track CAPAs, and verify implementation effectiveness.
• Review and approve supplier quality documentation, such as Technical/Quality Agreements, audit responses, change notifications, and deviation reports.
• Evaluate supplier quality systems and compliance with applicable international regulatory requirements (e.g., EMA, OECD GLP, VICH GCP, ISO/IEC *****, HACCP, etc.).
• Provide QA input into procurement decisions and cross-functional sourcing teams to ensure GxP compliance is considered in supplier selection.
• Support internal stakeholders (e.g., R additional languages are an asset.
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Specialized Knowledge or Skills • Solid knowledge of EU GMP, FDA regulations, OECD GLP, VICH GCP, and ICH guidelines.
• Proven ability to plan, conduct, and report external audits independently.
• Strong understanding of quality systems, technical agreements, and risk-based approaches to supplier qualification.
• Experience with quality investigations, CAPA management, and change control.
• Proficiency with QMS tools, audit tracking systems, and MS Office; experience with eQMS platforms preferred.
• Critical thinking, strong attention to detail, and ability to interpret complex regulations into operational requirements.
• Excellent communication and interpersonal skills; capable of engaging with diverse stakeholders globally.
• Willingness to travel domestically and internationally up to 25% The above job description is not intended to be an all-inclusive list of duties and standards of the position.
Incumbents will follow any other instructions, and perform any other related duties, as assigned by their direct manager.
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