Quality Manager – External Manufacturing & GMP

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, external manufacturing sites, suppliers and service providers.
• Review drug substance, drug product and finished product batch records, resolving issues with CMOs and supporting product release.
• Manage and execute core Quality Management System (QMS) processes including deviations, CAPAs, change controls and quality risk assessments.
• Conduct supplier qualification and GMP audits of CMOs, including audit follow-up, CAPA review and closure of observations.
• Support the development, implementation and ongoing management of Quality Agreements with CMOs.
• Maintain a state of inspection readiness and support regulatory and client inspections.
• Provide QA oversight and leadership for commercial product launches prior to distribution.
• Perform Annual Product Quality Reviews (APQR/PQR).
• Support complaint investigations involving manufacturing sites and distributors.
• Oversee supplier and service-provider quality performance.
• Represent Quality on cross-functional project teams, ensuring compliance with applicable cGMP requirements.
• Provide QA oversight of artwork changes and associated quality activities.
• Support GMP/GDP procedures, controlled documentation, training and electronic Quality/Document Management Systems.
• Provide guidance to cross-functional teams on relevant GMP regulations and quality requirements.
• Support transport duty-of-care and acceptance/release activities where required.

Experience & Qualifications

• Bachelor's degree in Life Sciences, Biochemistry, Microbiology, Pharmaceutical Science or a related discipline, or equivalent relevant industry experience.
• Approximately 5–7 years' experience within pharmaceutical Quality Assurance in a GMP-regulated environment.
• Strong working knowledge of EU GMP and FDA requirements for commercial pharmaceutical manufacturing.
• Hands-on experience with GMP Quality Systems, particularly deviations, CAPAs, change controls and risk assessments.
• Experience reviewing GMP documentation and executed batch records.
• Experience working with CMOs, external manufacturing partners, suppliers or contract service providers.
• Experience supporting or conducting GMP audits and supplier qualification activities.
• Strong documentation, investigation and compliance skills.
• Experience using eQMS/document management systems.
• Ability to manage multiple quality activities and priorities within a fast-paced environment.
• Experience within sterile pharmaceutical manufacturing.
• Commercial batch release / disposition support experience.
• Experience managing Quality Agreements with CMOs.
• APQR/PQR experience.
• Product launch or commercialisation QA experience.
• Experience supporting regulatory inspections.
• Understanding of virtual wholesaling / virtual pharmaceutical operations and CMO oversight.