Job Description:
Business Project Manager One in each Area Engineering Supply Chain Finance Operations Quality Assurance
Business Project Managers to lead high impact programs in manufacturing and supply chain operations driving operational excellence scaleup and commercial readiness
Overall this role requires project governance driving cross functional 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 cross functional ops teams and collaborate with stakeholders to drive business needs
As a Business Project Manager
Provide program leadership for complex Cross functional 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 Ator 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, workarounds are identified, and other issues surfaced are addressed
Qualifications
Bachelor's 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 high-tech strongly preferred
Demonstrated success managing technical projects and cross functional 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
Mandatory Skills :
Stakeholder Management, Benefits Management, Pursuit/ Proposal Management, Project Planning, Risk/Crisis Management, Project Governance, Account Management & Mining