Quality Manager

Quality Manager - External Manufacturing & GMP

Location: Dublin

We are seeking an experienced Quality Manager to provide GMP Quality oversight across commercial manufacturing, CMOs and external suppliers. The role will have responsibility for batch review/release support, QMS activities, supplier quality, audits and ongoing inspection readiness.

Key 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.

Experience & Qualifications

• 5-7 years' pharmaceutical Quality Assurance experience within a 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.
• Sterile manufacturing experience is advantageous.
• Understanding of virtual wholesaling and CMO oversight is desirable.