Building a robust, risk-based, supplier qualification process

Gabriele Sassi, Non Clinical Outsourcing Manager (CMC), CHIESI FARMACEUTICI SPA

ABSTRACT

When companies began outsourcing and globalizing the supply chain in the 1980’s and 1990’s, they did so without understanding the risks suppliers posed. Companies have begun implementing vendor management systems to assess and mitigate vendor risks to the supply chain.

But how to address this to the management of R&D service providers?

An extensive Qualification Process developed by R&D Outsourcing Management of Chiesi Farmaceutici. The process is aimed to risk reduction/avoidance with external suppliers of Corporate R&D and is divided into specific clusters assessing business and financial aspects, technical capabilities, quality requirements including important criteria on a sustainable supply chain and procurement.

BIOGRAPHY

Gabriele Sassi joined Chiesi Farmaceutici in 2010 and currently works as Non Clinical Outsourcing Manager in R&D Outsourcing Management, responsible for outsourcing R&D core activities for CMC such as Analytical Development, Clinical Trial Supplies and Drug Product / Drug Substance Manufacturing activities. Gabriele is mostly involved in establishing and managing the relationship with CROs and CMOs and the consequential contract management: this implies an intense knowledge of Procurement and Outsourcing processes that mainly refer to Supplier Selection and Qualification, Contract Awarding & Contract Management and Supplier Relationship Management. Gabriele has 9 years’ experience with procurement / outsourcing areas, starting his career in Procurement Department for Indirect Spend Categories (IT software, Laboratory Chemicals & Equipment).

 

COMPANY PROFILE

The Chiesi Group is an international company based in Parma, with more than 80 years of experience and a strong focus on research, development, production and the commercialisation of innovative medicines in the Respiratory, Neonatology, Rare Disease and Special Care Therapeutic Areas.

The Chiesi Group exports to more than 80 countries with a direct presence in 28, with a turnover of more than €1,768 millions sales.

Its R&D centres in Parma (Italy), Paris (France), Cary (USA), Chippenham and Oxford (UK) and Lidingo (Sweden), integrate their efforts to advance Chiesi's pre-clinical, clinical and registration programmes.

The Chiesi Group employs approximately 5,624 people, 788 of whom are dedicated to R&D activities and 809 of whom work at the production sites in Parma (Italy), Blois (France) and Santana De Parnaiba (Brazil).