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 750 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 nearly 90,000 talented and entrepreneurial professionals across more than 30 countries, LTIMindtree — a Larsen & Toubro Group company — combines the industry-acclaimed strengths of erstwhile Larsen and Toubro Infotech and Mindtree in solving the most complex business challenges and delivering transformation at scale. For more information, please visit www.ltimindtree.com.

Business Project Manager (“BPM”) for Regulatory and compliance

Location: Athenry, Galway at Ireland

Hybrid – 2 days a week

A Senior-level FACTORY Business Project Manager will lead a cross-functional business team in launching new FACTORY supply chain and manufacturing IT systems.

Essential Duties and Responsibilities:

• 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 data-driven manufacturing processes.
• Ensure compliance with applicable regulatory requirements (FDA, EU MDR, ISO standards).
• Collaborate with cross-functional 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 IQ/OQ/PQ 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 non-conformances.
• 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 routers/Bill Of Materials (BOMs) and associated milestones in manufacturing paperwork/transition to a digital platform an advantage.
• Experience in DHR/DHR management/collaboration through use of electronic systems MES.
• Experience audit presenting on electronic DHR an advantage.
• Knowledge software validation electronic records compliance (21 CFR Part 11).