Excellent opportunity for a QA Specialist to join a newly created Vaccines company in Ireland. This role offers the opportunity to act as a QA subject matter expert across GMP and other GxP standards, driving supplier oversight, audits, and risk-based quality management. With deep knowledge of international regulations and proven expertise in supplier qualification, you will play a key role in ensuring the highest quality standards across their global operations.
Overview of your responsibilities (full job description available on request)
1. Act as global QA SME for GxP supplier oversight (GMP, GLP, GCP, GDP).
2. Lead and improve supplier qualification programme (risk, audits, monitoring).
3. Conduct audits, issue reports, track CAPAs, verify effectiveness.
4. Review/approve supplier docs: agreements, responses, changes, deviations.
5. Assess supplier quality systems vs global regs (EMA, OECD GLP, VICH GCP, ISO, HACCP).
6. Advise on procurement to ensure GxP compliance in supplier selection.
7. Support teams (R&D, QC, Regulatory, Procurement) in supplier investigations.
8. Deliver internal training on supplier qualification.
Knowledge, Skills and Experience Required for the Role:
9. Degree in Life Sciences, Pharmacy, Biotech, or related field
10. 7–10 years' QA experience in pharma, biologics, or vaccines
11. 5+ years hands-on in GxP supplier qualification & auditing (GMP + GLP/GCP/GDP)
12. Bonus: experience with labs, contract manufacturing, or clinical service providers
13. Strong knowledge of EU GMP, FDA, OECD GLP, VICH GCP & ICH guidelines
14. Skilled in planning, conducting & reporting audits independently
15. Deep understanding of quality systems, agreements & risk-based supplier qualification
16. Experienced in investigations, CAPA management & change controls