Role description

Business Project Manager BPM for Regulatory and compliance

Position Summary

Seniorlevel FACTORY Business Project Manager will lead a crossfunctional business team in launching new FACTORY supply chain and manufacturing IT systems

The 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 businessproposed IT solutions and systems and manage postrelease activities

Essential Duties and Responsibilities

Working 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 objectives

Ensure all project objectives are achieved on time and within budget while meeting applicable corporate policies Regulatory and Quality Management System requirements

Lead 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 members

Develop 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 required

Acting as the primary point of contact for stakeholders and business partners provide regular progress updates and facilitate communication between teams

Identify and resolve issues that arise during the project and adapt plans to accommodate changes

Establish programproject governance to provide support for decisions and critical risks

Excel in a fast paced and dynamic environment while managing multiple tasks and timelines

Perform other duties as assigned

Required Qualifications

Business maturity and emotional intelligence

Able to work onsite at the Ireland facility in Athenry

Strong communication skills that can effectively facilitate discussions and communicate with teams and executive leaders

Maintain and improve the Quality Management System QMS in alignment with ISO 13485 and FDA regulations

Support digital transformation initiatives by integrating quality controls into automated and datadriven manufacturing processes

Ensure compliance with applicable regulatory requirements FDA EU MDR ISO standards

Collaborate with crossfunctional teams to embed quality assurance into digital workflows MES Manufacturing Execution Systems and ERP systems

Monitor and validate data integrity across digital platforms used in production and quality control

Support implementation of predictive analytics and AI tools for quality monitoring and defect prevention

Lead or support IQOQPQ activities for new digital equipment and software systems

Review and approve validation protocols technical documentation and change controls

Maintain accurate and timely documentation of quality activities including CAPAs SCARs and nonconformances

Prepare for and participate in internal audits FDA Notified Bodies

Conduct periodic reviews of trending analysis of quality metrics and digital system performance

Ensure audit readiness of digital systems and electronic records

Train staff on using tools regulatory requirements QMS procedures

Provide guidance on data governance cybersecurity and digital traceability in regulated environments

Experience in management of routersBill Of Materials BOMs and associated milestones in manufacturing paperworktransition to a digital platform an advantage

Experience in DHRDHR managementcollaboration through use of electronic systems MES

Experience audit presenting on electronic DHR an advantage

Knowledge software validation electronic records compliance 21 CFR Part 11