Giovanni Lentini

Strategic Digital Technology Leader | Driving AI & Automation in Pharma Regulatory Operations | Agile Delivery & Product Leadership

Basel Metropolitan Area

About

Strategic Digital Technology Leader with 15 years of experience driving digital transformation within the global Pharmaceutical sector. Recognized for architecting scalable, future-proof regulatory systems and leading high-performing agile delivery squads. Passionate about bridging the gap between complex business needs and cutting-edge technology, with a proven track record of cultivating talent, fostering cross-divisional collaboration, and delivering enterprise-grade solutions that compress project timelines and generate massive operational savings.

Experience

  • Roche Digital Technology Regulatory Product Manager at Roche
    May 2015 - Present · 11 yrs 3 mos

    Progressive leadership roles driving enterprise-wide digital innovation, automation, and regulatory technology strategy. • STRATEGIC ROADMAPPING: Directed the global digital technology roadmap for submission publishing and archiving. Partnered with Regulatory Leadership to translate evolving business needs into a strategic portfolio, driving investments in automation, data submissions, and eCTD 4.0 readiness. • AI & STRUCTURED CONTENT GENERATION: Leading enterprise use cases for AI-driven document content generation and clinical datasets. Pioneering the use of agentic AI and structured content reuse to modernize regulatory workflows, directly compressing major drug filing timelines from 12 weeks to 6 weeks. • AUTOMATION AT SCALE: Built and scaled a centralized Automation Factory. Directed up to 4 concurrent agile squads to deliver enterprise Robotic Process Automation (RPA) use cases that eliminated administrative bottlenecks and generated over 100,000 hours in annual operational savings. • TEAM CAPABILITY & MENTORSHIP: Actively championed servant leadership by mentoring engineers and Business Analysts. Empowered team members to take cross-project ownership and successfully transition into lead roles. • ENTERPRISE PRODUCT DELIVERY: Co-led the global rollout of Veeva RIM for publishing and archiving. Decommissioned legacy tools in favor of enterprise platform adoption, unifying digital capabilities across global affiliates. • CROSS-DIVISIONAL DELIVERY: Bridged the gap between Pharma and Diagnostics divisions by leading a global country requirements database from MVP through full solution deployment, breaking down organizational silos.

  • IT Business Analyst – Quality Assurance & Regulatory Affairs at Novartis
    Jul 2009 - Apr 2015 · 5 yrs 10 mos

    • END-TO-END IMPLEMENTATION: Directed the delivery of the enterprise submission publishing solution (Liquent Publisher) for Vaccines, managing the entire product lifecycle from vendor selection through global go-live and support. • CROSS-FUNCTIONAL DELIVERY: Led the rollout of a global regulatory submissions tracking tool (TrackWise). Managed comprehensive User Requirement Specifications (URS) and partnered with technical experts to translate complex business needs into fully compliant capabilities. • AGILE CONTINUOUS IMPROVEMENT: Drove continuous product enhancements within the enterprise Quality Assurance ecosystem. Rapidly designed and deployed system optimizations to ensure strict compliance with highly time-critical Health Authority (HA) regulations. • STRATEGIC ROADMAPPING: Partnered with QA and Regulatory business leaders to define and execute 3-5 year technology roadmaps and global rollout plans.

  • Management Consultant at Conzorzio QuInn
    Jun 2008 - Jul 2009 · 1 yr 2 mos

    • CLIENT-CENTRIC PROCESS REENGINEERING: Partnered with enterprise and government clients to drive Business Process Reengineering (BPR) and digital workflow automation. Cultivated a strong customer-first consulting approach by translating client needs into optimized financial and operational processes. • QUALITY & COMPLIANCE FOUNDATION: Executed the comprehensive revision and implementation of Quality Management Systems (ISO 9001:2008) for regional agencies, building a strong early foundation in strict regulatory frameworks and quality assurance.