Role description Location Athenry Galway Ireland or in Close Proximity working in Ireland timezone Seeking Business Project Managers to lead highimpact programs in manufacturing and supply chain operations driving operational excellence scaleup and commercial readiness Overall 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 needs As a Business Project Manager

Provide program leadership for complex crossfunctional operations projects from inception through commercialization Drive commercial readiness for the Athenry facility including new equipment moulds automation qualification implementation and technology transfers Lead production scaleup of products and processes including Change Order Plan (COP) closure and FDA filing support where required Partner across technical teams mechanical process electrical automation software and business functions manufacturing procurement logistics facilities EHS quality regulatory finance IT in a highly matrixed environment Collaborate with suppliers and external manufacturing partners to ensure successful project delivery Establish and execute project strategies schedules and resource plans anticipating risks and driving mitigation Ensure compliance with medical device regulatory standards FDA ISO EU MDR GMP Communicate project plans risks and progress clearly to leadership and stakeholders Articulate the scope and MVP of the work effort ie the work product to be delivered by IT Represent functional interests and provide the voice of the function at all governance and related key milestone delivery points throughout the projects duration Works with the projects functional team to identify the list of features comprising the work product Manages and prioritizes features in a product backlog template including additions modifications or other changes to backlogged work Releases features from the product backlog in priority order as the work effort progresses Works with the projects functional team to ensure representation at above levels necessary to conduct all discovery design planning development and other related collaboration efforts throughout the projects duration Works with the projects functional team to articulate and confirm acceptance criteria for all deliverable work as part of delivery and testing efforts Responsible for collaboration with IT leads and validation information security teams to perform required validation and infosec assessments and address any ongoing validation information security requirements Responsible 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 requirements Works with the projects functional team to ensure the Hypercare process is effective defects and workarounds are identified and other issues surfaced are addressed

Qualifications

Bachelors degree in Engineering Supply Chain Business or related discipline Masters preferred 12 years experience in project or program management within manufacturing engineering or supply chain medical devices pharma or hightech strongly preferred Demonstrated success managing technical projects and crossfunctional teams Knowledge of automation equipment qualification and manufacturing transfer Strong grasp of regulated change control product development processes and design control Strong knowledge of manufacturing processes global supply chain operations and ERP systems SAP Oracle others Familiarity with ERPMESWMS systems and operational excellence initiatives Experience working in regulated industries FDA ISO13485 EU MDR is a plus Excellent communication and stakeholder management skills able to influence ac

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