Vaccines Quality Specialist

2 days ago


Sligo, Sligo, Ireland beBeeQuality Full time €100,000 - €130,000
Quality Assurance Expert Sought

An exciting opportunity for a quality assurance specialist to excel in a newly established vaccines company in Ireland.

This role offers the chance to serve as a QA subject matter expert across GMP and other GxP standards, driving supplier oversight, audits, and risk-based quality management.

Main Responsibilities:
  • Act as global QA SME for GxP supplier oversight (GMP, GLP, GCP, GDP).
  • Lead and improve supplier qualification program (risk, audits, monitoring).
  • Conduct audits, issue reports, track CAPAs, verify effectiveness.
  • Review/approve supplier documents: agreements, responses, changes, deviations.
  • Assess supplier quality systems vs global regulations (EMA, OECD GLP, VICH GCP, ISO, HACCP).
  • Advise on procurement to ensure GxP compliance in supplier selection.
  • Support teams (R&D, QC, Regulatory, Procurement) in supplier investigations.
  • Deliver internal training on supplier qualification.
Required Skills and Qualifications:
  • Degree in Life Sciences, Pharmacy, Biotech, or related field.
  • 7–10 years' QA experience in pharma, biologics, or vaccines.
  • 5+ years hands-on in GxP supplier qualification & auditing (GMP + GLP/GCP/GDP).
  • Bonus: experience with labs, contract manufacturing, or clinical service providers.
  • Strong knowledge of EU GMP, FDA, OECD GLP, VICH GCP & ICH guidelines.
  • Skilled in planning, conducting & reporting audits independently.
  • Deep understanding of quality systems, agreements & risk-based supplier qualification.
  • Experienced in investigations, CAPA management & change controls.

Please contact Courtney Russell for a confidential discussion and more information on this role.



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