Seasoned Quality and business professional with 30+ years of experience in Quality & Compliance functions within pharma and biotech industries. Passion to lead & develop people & organization to contribute to the company's growth strategy.

Leading the Global Quality External Operations Organization accountable for all aspects of GxP Quality/Compliance Operations and product release to market/clinical trials across the entire Sobi external supplier network worldwide, through robust quality oversight from development to commercial products.

Leading the strategy and execution of the Quality Assurance operations for clinical and commercial Biogen products manufactured at contract manufacturing organizations (CMOs). Leading teams (US, EU, international) that are responsible for supply chain quality engineering, quality systems, Management review and product release groups.Accountable to ensure compliance with global regulatory standards at Biogen and third‐party facilities and to provides Quality expertise to internal and external partners related to Technology Transfer, Validation and Manufacturing, Investigations/CAPA management, Change and Risk Management.

I'm responsible for the continued development of the V&D Quality strategy in alignment with the Novartis group Quality Operations strategy; this is accomplished through identification and clarification of quality initiatives to improve the complance aspects and the effectiveness of the quality systems in V&D.I'm also responsible for managing portfolio of global projects and Programs, the quality plan, Quality Unit budget and proper quality resource planning.Site Head of Quality for the Basel site.

I'm responsible for managing the Quality Organization of the Italian Novartis Vaccine Sites (Siena and Rosia). I lead an organization of 400 people involved in the manufacture of several vaccines (Bulk, formulation, aseptic filling and secondary packaging).