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
Skills
Mandatory Skills : Regulatory & Compliance - Computer system validation,Regulatory & Compliance - Process Quality Assurance
About LTIMindtree
LTIMindtree is a global technology consulting and digital solutions company that enables enterprises across industries to reimagine business models, accelerate innovation, and maximize growth by harnessing digital technologies. As a digital transformation partner to more than 700 clients, LTIMindtree brings extensive domain and technology expertise to help drive superior competitive differentiation, customer experiences, and business outcomes in a converging world. Powered by 83,000+ talented and entrepreneurial professionals across more than 40 countries, LTIMindtree — a Larsen & Toubro Group company — solves the most complex business challenges and delivers transformation at scale. For more information, please visit