Quality Assurance Director

17 hours ago

Sligo, Sligo, Ireland beBeeSupplier Full time €80,000 - €100,000
Quality Assurance Professional

A strategic opportunity exists for a seasoned Quality Assurance professional to join an innovative vaccines company in Ireland. This role offers the chance to act as a Quality Assurance subject matter expert across GMP and other GxP standards, driving supplier oversight, audits, and risk-based quality management.

Key Responsibilities:

  • Act as global Quality Assurance 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 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.

Requirements:

  • 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.

We are seeking a highly skilled professional to take on this challenging role.

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