Nicola is a Senior Quality Consultant based in The Netherlands with over 30 years of extensive experience in the pharmaceutical industry dealing with the manufacturing of APIs and Finished Dosage Forms, including Sterile and biological products. He is an EU Qualified Person since 2004.
Nicola has expertise in Quality Systems Management, including but not limited to Audit Readiness (FDA, EMA, Local Health Authorities, Customers), Sterility Manufacturing, GMP Compliance assessment, and a solid background in Analytical Chemistry.
Prior to joining Orphan Drug Consulting, Nicola has held key quality management and/or QP roles in several companies across Europe such as Pfizer, Sandoz (Novartis Company), Centrient (formerly DSM Sinochem Pharmaceuticals), and most recently he held the position of QA project lead in Johnson & Johnson. He has contributed to the design, implementation, and maintenance of effective pharmaceutical quality systems and executed multiple internal and supplier audits focused on GMP, GDP, and Regulatory compliance.
Nicola holds a Masters's Degree in Chemistry from “Federico II” University in Naples, Italy.