GMP Quality Lead — External Manufacturing & Compliance

Next Generation; Dublin; On-site; EUR 90,000 - 130,000; Full time

Job summary

Next Generation is seeking an experienced Quality Manager to provide GMP QA oversight across commercial manufacturing, CMOs and external suppliers in Dublin. The role covers batch review and release support, QMS activities, supplier quality, audits and ongoing inspection readiness.

The ideal candidate will have 5–7 years of pharmaceutical QA experience in a GMP environment, a Life Sciences-related degree, and strong knowledge of EU GMP and FDA regulations.

Qualifications

• 5–7 years pharmaceutical QA experience within GMP environment.
• Degree in Life Sciences, Biochemistry, Microbiology or related discipline.
• Strong knowledge of EU GMP and FDA regulations.
• Experience with CMO/external manufacturing and supplier quality oversight.
• Hands-on experience with batch review, QMS and GMP auditing.
• Experience with eQMS/document management systems.

Responsibilities

• Provide QA oversight of CMOs, manufacturing partners, suppliers and service providers.
• Review drug substance, drug product and finished-product batch records and support product release.
• Manage deviations, CAPAs, change controls and quality risk assessments.
• Conduct CMO/supplier qualification and GMP audits, including CAPA follow-up.
• Develop and maintain Quality Agreements with external manufacturing partners.
• Support regulatory inspections, complaint investigations and inspection readiness.
• Complete Annual Product Quality Reviews (APQR/PQR).
• Provide Quality oversight for commercial product launches and artwork changes.
• Represent Quality on cross-functional teams and ensure continued GMP compliance.

Skills

GMP QA Oversight

Batch review & release

GMP auditing

QMS / document management

Regulatory inspections readiness

Supplier quality oversight

Education

Life Sciences degree

Biochemistry or Microbiology background

Tools

eQMS

Job description

Next Generation is seeking an experienced Quality Manager to provide GMP QA oversight across commercial manufacturing, CMOs and external suppliers in Dublin. The role covers batch review and release support, QMS activities, supplier quality, audits and ongoing inspection readiness.

The ideal candidate will have 5–7 years of pharmaceutical QA experience in a GMP environment, a Life Sciences-related degree, and strong knowledge of EU GMP and FDA regulations.