QA Specialist - Supplier & Vendor

• Opportunity to be part a diverse team and an established company which offer career progression opportunities.
• They put their people first and live their diversity and inclusion values embracing all perspectives.
• Competitive salary & benefits package.

• 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 17025, 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&D, Manufacturing, QC, Regulatory Affairs, Procurement) in supplier-related investigations and risk assessments.
• Develop and deliver internal training on supplier qualification procedures and regulatory expectations.
• Represent QA in cross-functional teams involving outsourced activities, ensuring the integrity of GxP-related data and deliverables.
• Maintain accurate and current records in eQMS systems and supplier management databases.

• Bachelor’s degree or higher in Life Sciences, Pharmacy, Biotechnology, or a related scientific discipline.
• Minimum of 7–10 years of QA experience in the pharmaceutical, biologics, or veterinary vaccine industry.
• At least 5 years of hands-on experience in GxP supplier qualification and auditing, with demonstrated expertise in GMP and at least one of the following: GLP, GCP, GDP.
• Experience with laboratory testing, contract manufacturing, and/or clinical service providers preferred.
• Proficiency in English (written and oral); additional languages are an asset.
• 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%

Team Horizon