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 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.

Education and or Work Experience Requirements
•    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..

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.