Supplier Quality

5 days ago

Dublin, Ireland Cpl Full time

Supplier Quality (Senior) SpecialistMy client, an international pharma company specialising in Oncology and Endocrinology, is growing their team in Dublin and is now seeking a talented Supplier Quality (Senior) Specialist.Work with a company who are 'Family First' and offer flexibility, remote working and a close knit, inclusive team. 1 day per week in the office in Dublin city centre, with flexibility around business needs.Purpose & ScopeThis role is primarily responsible for overseeing supplier quality processes including change control, quality agreements, supplier audits, and inspection readiness—focusing on Contract Manufacturing/Packaging Organizations (CMOs/CPOs)Key ResponsibilitiesManage Supplier Change Notification Program and perform impact assessmentsOwn supplier-related deviations and SCARs, including investigationsSupport quality agreement lifecycle from initiation to coordinationParticipate in internal/supplier audits under QA Auditor guidanceHandle supplier qualification/re-evaluation, risk and quality assessmentsAuthor and revise departmental proceduresAssemble data for Annual Product Quality Review (APQR)Conduct supplier site visits for investigationsLead inspection readiness and employee training initiativesSupport external audits/inspections (FDA, Notified Bodies, etc.)Handle post-inspection follow-ups and documentationPerform other duties as assignedRequired Knowledge, Skills & AbilitiesStrong understanding of GMP/cGMP and international regulations:Experience with supplier quality, deviation handling, and change controlProficient in technical writing, communication, collaboration, and trainingAble to work independently and prioritize deadlinesComputer literacy: Microsoft Office Suite (Word, Excel, PowerPoint, etc.)Core Values AlignmentCandidates must demonstrate alignment with our Core Values:Centre on PeopleAre Proactive & AgileAct EthicallyConstantly ImproveAre AccountableQualificationsEducation:Bachelor’s degree in a scientific discipline requiredExperience:3-5 years for Specialist and 6-10 years for Manager role pharmaceutical Quality Assurance/Control rolesExperience with API suppliers highly desirablePreferred: Supplier/raw material management, audit experience, inspection readinessWorking ConditionsStandard schedule: Mon–Fri, 8am–5pm, with flexibility for overtimeUp to 10% travel, including domestic and occasional internationalIdeal Candidate ProfileThis role suits someone who:Has a solid foundation in GMP/QMS principlesIs comfortable taking ownership of quality events and supplier relationshipsCan effectively across technical, QA, and supply chain teamsEnjoys auditing, documentation, and inspection prepBrings a proactive mindset aligned with regulatory excellence and process improvement#LI-SD1

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