Dr. Luigi De Rosa

• Serve as end-to-end accountable owner for 6 External Manufacturing Partners across Europe and Asia, managing production of 12 APIs incorporated into 30 drug products distributed globally, with approximately $50M in annual manufacturing spend. • Lead a cross-functional Focus Factory team of 10 across Supply Chain, Quality, Procurement, Regulatory, and MSAT, driving accountability, supply reliability, and continuous improvement across the CMO network.

• Directly managed a team of 4 Senior Quality Managers overseeing quality operations across 3 external manufacturing partners, with combined output of approximately 100 batch releases per year across 30+ product variants. • Maintained quality oversight across complex dosage forms including sterile injectables, lyophilized products, creams, sprays, and oral solid dosage forms, ensuring compliance with FDA, EMA, and Swissmedic requirements.

• Led quality governance for a global CMO network producing sterile pharmaceuticals, APIs, biologics, non-sterile products, drug delivery devices, and consumer healthcare products across multiple markets. • Directed external partner selection, GMP due diligence, and qualification for new CMO partnerships, evaluating manufacturing, analytical, and quality system capabilities prior to contract award.

Managed the relationship with assigned suppliers in EU and Asia from a Quality perspective to ensure that all aspects of the products comply with the requirements of the GSK Quality Manual and meet relevant cGMP, regulatory and legislative requirements, through defined key performance and quality indicators.

Primary point of contact for all Quality Related Items/Issues with Manufacturing Sites and Aspen Affiliates worldwide (deviations, OOS/OOE, complaints, CAPA, recalls, counterfeits and product tampering, stability failures, etc.).

Acted as Single Point of Contact (SPOC) for all quality related activities at the Third Party Suppliers, ensuring that all aspects of the handling, manufacturing and distribution of pharmaceutical products were in compliance with relevant cGMP, regulatory requirements, the Novartis Quality Manual and the effective Quality Agreements.

Issue and Review of Quality Procedures and SOPs. Batch Record review. GMP documents review and approval. GMP compliance activities for Active Pharmaceutical Ingredients (API) and food products: change control management, deviations, review of deviation investigation reports. Review of specifications and analytical methods of raw materials, finished and intermediate products. Execution of Self-Inspections Audits. Support for FDA Regulatory Inspections preparation and management.

Implemented quality, environment and safety management systems for manufacturing and service companies. Realized Hazard Analysis and issued HACCP manuals and food safety management systems for food manufacturing and retailers. Performed environmental consulting (focused on waste management, noise, air emissions, water discharges). Executed both internal and external audits of management systems of different types of companies.

• Molecular characterization of bacterial communities involved in the “Toscano” cigar fermentation. • Design, management and execution of research projects particularly in the molecular biology and microbiology fields.

Molecular and Industrial Biotechnologies

Industrial Biotechnologies