Quality Assurance Project Manager

4 weeks ago

Galway, Ireland 360 Technology Full time

Position:Business Project Manager – QA (Regulatory & Digital Transformation)Location:Athenry, Ireland and HybridExperience:8+ years (with strong QA/Regulatory project management background)Domain:Medical Device / Life Sciences / Regulated ManufacturingJob Summary:We are seeking aBusiness Project Manager (QA – Regulatory)to lead initiatives focused on enhancing Quality Management Systems (QMS) and driving digital transformation within regulated manufacturing environments.The ideal candidate will have strong experience in Quality Assurance, regulatory compliance (FDA, ISO *****, EU MDR), and digital systems integration (MES, ERP, eQMS).Key Responsibilities:Quality & Regulatory ManagementMaintain and continuously improve theQuality Management System (QMS)in alignment withISO *****,FDA regulations, and other global standards.Ensure compliance with applicableregulatory requirements(FDA, EU MDR, ISO, 21 CFR Part 11).Support preparation for and participation ininternal and external audits(FDA, Notified Bodies).Oversee documentation and management ofCAPAs, SCARs, deviations, and non-conformances.Digital Transformation & System IntegrationIntegratequality controlsinto automated, data-drivenmanufacturing and digital workflows.Collaborate with IT, Manufacturing, and QA teams to embed quality assurance intoMES (Manufacturing Execution Systems)andERP systems.Monitor and validatedata integrityacross digital platforms used in production and quality control.Lead or supportIQ/OQ/PQ validation activitiesfor new digital equipment and software systems.Review and approvevalidation protocols, change controls, and technical documentation.Data, Analytics & ComplianceEnsureaudit readinessand compliance of digital systems and electronic records.Conductperiodic trending analysisof quality metrics and digital system performance.Supportpredictive analytics and AI-based quality monitoringinitiatives.Provide guidance ondata governance, cybersecurity, and digital traceability.Training & CollaborationTrain cross-functional teams onQMS procedures,regulatory requirements, and use ofdigital QA tools.Collaborate with engineering, manufacturing, and IT to ensure compliance and quality integration in all digital initiatives.Preferred Experience & Skills:Proven experience inQuality Assurance or Project Managementwithinregulated industries(medical device, life sciences, pharma, or manufacturing).Strong understanding ofISO *****, FDA QSR, EU MDR, and21 CFR Part 11compliance.Experience managingrouters/Bill of Materials (BOMs)and digital manufacturing transitions.Hands-on experience withelectronic DHR/DHR managementand presenting during audits.Knowledge ofsoftware validation,electronic records compliance, anddigital QMS systems.Experience leadingcross-functional digital transformation projectsin a regulated setting.Excellent communication, stakeholder management, and documentation skills.Education & Certification:Bachelor's or Master's degree in Engineering, Life Sciences, Quality, or related field.PMP, Six Sigma, or Quality Management certifications (CQE, CQA) preferred

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