
Quality Assurance Specialist: Global Expert in Supplier Oversight
1 day ago
About our organization
We are a global company with a rich history in animal health and nutrition as a manufacturer and marketer of medicated feed additives, vaccines, nutritional specialty products, and mineral nutrition.
Our goal is to be a trusted partner with livestock producers, farmers, veterinarians, and consumers who raise or care for farm and companion animals by providing solutions to help them maintain and enhance the health of their animals.
We strive to develop a diverse workforce that fosters an environment where people feel supported in openly sharing their creativity and skills that allows them to be the most successful they can be.
If you are interested in working for us and feel that you do not meet all qualifications, we encourage you to apply as you might be the right candidate for this role or other positions.
The Quality Assurance Specialist - GxP Supplier and Vendor Oversight is an integral part of our Quality Assurance team based out of our Ireland - Sligo site.
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.
- 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%
Benefits
To learn more about our competitive benefits package, please click here: [link]
Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, gender identity, veteran status, marital status or any other characteristics protected by law.
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