Role DescriptionLocation Athenry Galway Ireland or in Close Proximity working in Ireland timezoneBusiness Project Managers to lead highimpact programs in manufacturing and supply chain operations driving operational excellence scaleup and commercial readinessOverall this role requires project governance driving crossfunctional teams to help bring their Athenry facility to commercial readiness interacting with production planning and procurement to help define logistics of SKU changes and inventory planning and managing equipment design development and qualification to build product at internal and external manufacturing locations The Business Project Managers will lead crossfunctional ops teams and collaborate with stakeholders to drive business needsAs a Business Project ManagerProvide program leadership for complex crossfunctional operations projects from inception through commercializationDrive commercial readiness for the Athenry facility including new equipmentmouldsautomation qualification implementation and technology transfersLead production scaleup of products and processes including Change Order Plan COP closure and FDA filing support where requiredPartner across technical teams mechanical process electrical automation software and business functions manufacturing procurement logistics facilities EHS quality regulatory finance IT in a highly matrixed environmentCollaborate with suppliers and external manufacturing partners to ensure successful project deliveryEstablish and execute project strategies schedules and resource plans anticipating risks and driving mitigationEnsure compliance with medical device regulatory standards FDA ISO EU MDR GMPCommunicate project plans risks and progress clearly to leadership and stakeholdersArticulates the scope and MVP of the work effort ie the work product to be delivered by ITRepresents functional interests and provides the voice of the function at all governance and related key milestone delivery points throughout the projects durationWorks with the projects functional team to identify the list of features comprising the work productManages and prioritizes features in a product backlog template including additions modifications or other changes to backlogged workReleases features from the product backlog in priority order as the work effort progressesWorks with the projects functional team to ensure representation atorabove levels necessary to conduct all discovery design planning development and other related collaboration efforts throughout the projects durationWorks with the projects functional team to articulate and confirm acceptance criteria for all deliverable work as part of delivery and testing effortsResponsible for collaboration with IT leads and validationinformation security teams to perform required validation and infosec assessments and address any ongoing validationinformation security requirementsResponsible for collaboration with IT leads and privacy team to perform required privacy assessments and data mapping processes for the work effort and address any ongoing privacy requirementsWorks with the projects functional team to ensure the Hypercare process is effective defects and workarounds are identified and other issues surfaced are addressedQualificationsBachelors degree in Engineering Supply Chain Business or related discipline Masters preferred12 years experience in project or program management within manufacturing engineering or supply chain medical devices pharma or hightech strongly preferredDemonstrated success managing technical projects and crossfunctional teamsKnowledge of automation equipment qualification and manufacturing transferStrong grasp of regulated change control product development processes and design controlStrong knowledge of manufacturing processes global supply chain operations and ERP systems SAPOracle othersFamiliarity with ERPMESWMS systems and operational excellence initiativesExperience working in regulated industries FDA ISO13485 EU MDR is a plusExcellent communication and stakeholder management skillsable to influence acSkillsMandatory Skills :Stakeholder Management,Benefits Management,Pursuit/ Proposal Management,Project Planning,Risk/Crisis Management,Project Governance,Account Management & Mining