Business Project Manager BPM for Regulatory and compliancePosition SummarySenior level FACTORY Business Project Manager will lead a cross functional business team in launching new FACTORY supply chain and manufacturing IT systemsThe Business Project Manager Business BPM acts as the voice of the business on activities that drive collaborative IT project work efforts from start to finish They act as the key liaison and go between among participating business teams the IT project manager and the various IT technical and testing teams working collaboratively to organize plan control execute test and release business sproposed IT solutions and systems and manage post release activitiesEssential Duties and ResponsibilitiesWorking as a Business Project Manager and partnering with Client IT Project Managers and multiple external resources to build maintain and execute the FACTORY business plan endtoend that align with Client global operations objectivesEnsure all project objectives are achieved on time and within budget while meeting applicable corporate policies Regulatory and Quality Management System requirementsLead FACTORY project launches and establish development testing and production readiness by working with multiple internal external and global teams to ensure project deliverables are completed on time and meet quality standards low defect rates Drive actionable items across a range of departments Align and communicate timely program status to stakeholders sponsors and team membersDevelop program charter consolidate program milestones interdependencies to build an integrated roadmap plan training programs with the training team and create execution and communication plans as requiredActing as the primary point of contact for stakeholders and business partners provide regular progress updates and facilitate communication between teamsIdentify and resolve issues that arise during the project and adapt plans to accommodate changesEstablish programproject governance to provide support for decisions and critical risksExcel in a fast paced and dynamic environment while managing multiple tasks and timelinesPerform other duties as assignedRequired QualificationsBusiness maturity and emotional intelligenceAble to work onsite at the Ireland facility in AthenryStrong communication skills that can effectively facilitate discussions and communicate with teams and executive leadersMaintain and improve the Quality Management System QMS in alignment with ISO 13485 and FDA regulationsSupport digital transformation initiatives by integrating quality controls into automated and datadriven manufacturing processesEnsure compliance with applicable regulatory requirements FDA EU MDR ISO standardsCollaborate with crossfunctional teams to embed quality assurance into digital workflows MES Manufacturing Execution Systems and ERP systemsMonitor and validate data integrity across digital platforms used in production and quality controlSupport implementation of predictive analytics and AI tools for quality monitoring and defect preventionLead or support IQOQPQ activities for new digital equipment and software systemsReview and approve validation protocols technical documentation and change controlsMaintain accurate and timely documentation of quality activities including CAPAs SCARs and nonconformancesPrepare for and participate in internal audits FDA Notified BodiesConduct periodic reviews of trending analysis of quality metrics and digital system performanceEnsure audit readiness of digital systems and electronic recordsTrain staff on using tools regulatory requirements QMS proceduresProvide guidance on data governance cybersecurity and digital traceability in regulated environmentsExperience in management of routersBill Of Materials BOMs and associated milestones in manufacturing paperworktransition to a digital platform an advantageExperience in DHRDHR managementcollaboration through use of electronic systems MESExperience audit presenting on electronic DHR an advantageKnowledge software validation electronic records compliance 21 CFR Part 11SkillsMandatory Skills :Regulatory & Compliance - Computer system validation,Regulatory & Compliance - Process Quality Assurance