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 equipmentmouldsautomation 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

Articulates the scope and MVP of the work effort ie the work product to be delivered by IT

Represents functional interests and provides 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 atorabove 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 validationinformation security teams to perform required validation and infosec assessments and address any ongoing validationinformation 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 SAPOracle 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 skillsable to influence ac