Marco Pulcini Email & Phone Number

Healthcare professional with 15 years of experience in Quality and Regulatory with a focus on Compliance in Supply Chain. Trilingual, fluent in English, Spanish and Portuguese.Excellent presenter. Comprehensive background includes successful work and leadership in the local, regional and global Supply Chain network of internal and external sites in key quality pillars such as Quality Systems, Quality Assurance, Quality Control, Medical/Clinical Supplies, Supplier Quality and Audits. Always pursuing the highest standards of quality, ethics, compliance, efficiency and ethics through strategic leadership with a focus on customer and consumer satisfaction and business needs. BSc in Biomedical Sciences, postgraduate degrees in Toxicology and Quality Control.Overall responsibilities and portfolio of achievements include remediation and sustainability of the quality and compliance profile in the sites covered by the QMS, including commercial offices, distribution centers and suppliers and distributors partners, attending enterprise and health authority expectations. Remarkable results in audits and supplier assessment program, readiness for audits and inspections. Significant performance at Pinex, J&J and DHL employers. Implemented intensive internal training for auditors that saved 20K in 2023 replacing external training.Conducted on-site audits at more than 60 carriers per year at transportation service providers. Supervised internal audits, 15 sites at J&J and 7 sites at DHL. Led the Purchasing Controls Process for GxP suppliers and distributors: J&J over than 600 suppliers/180 distributors; DHL 100 suppliers.Expert in regulations for the import, storage, distribution and transport of products. For Brazil it includes ANVISA, INMETRO, IBAMA (environmental), CETESB (environmental), Fire Department regulations (AVCB) and IATA/ANAC/ANTT dangerous goods regulations.Helped orchestrate projects for business acquisitions and divestitures, product launches, field actions, recalls and discontinuations. Site commissioning and decommissioning.Deep interaction with the areas of Quality, Regulatory Affairs, Technical Services, Copy Review, Marketing, Logistics, Warehousing and Transport, Facilities, Maintenance and EHS.Experience supporting the Pharmaceuticals, Medical Devices, Consumer Goods, Nutraceuticals and Sanitizers business segments. Expertise in the areas of Logistics, Supply Chain, 3PL, Import, Distribution, Warehousing, Transport, Wholesale, Clinical Laboratory, Higher Education, Hospital and Home Care Nursing.

Listed skills include Regulatory Affairs, Quality Assurance, Gmp, Medical Devices, and 39 others.