Quality Specialist

Overview

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.

Responsibilities

• Act as global QA SME for GxP supplier oversight (GMP, GLP, GCP, GDP).
• Lead and improve supplier qualification programme (risk, audits, monitoring).
• Conduct audits, issue reports, track CAPAs, verify effectiveness.
• Review/approve supplier docs: agreements, responses, changes, deviations.
• Assess supplier quality systems vs global regs (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.

Knowledge, Skills and Experience

• 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

For a confidential discussion and more information on the role contact Courtney Russell

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