Overview of your responsibilities
full job description available on request
* 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 Required for the Role:
* 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
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062
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