Catalent launches Quality, Product Development & Regulatory Affairs organization
Catalent Pharma Solutions, a Somerset, N.J.-based global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, has formed the Quality, Product Development & Regulatory Affairs organization, established to build upon Catalent’s experience in new product development, regulatory excellence, reliable supply and quality. Sharon Johnson, senior vice president, global quality & regulatory affairs, will head up Catalent’s new organization.
One of the key functions of the new organization will be to focus further on partnering with customers as part of Catalent’s New Product Introduction Excellence program. A factor in Catalent’s revenue and growth strategy, the program has expanded at a rate of over 70% over the past three years, from 59 new product launches globally in 2012, to 97 in 2013 and 175 in 2014.
“The overall goal of the Quality, Product Development & Regulatory Affairs organization will be to drive excellence and reliability across all of the products that we make and deliver,” said Johnson. “Our customer promise not only is to provide a reliable supply of their current, ongoing products, but to deliver new products with the same rigorous commitment to excellence. Bringing together these two functions into one team will tighten collaboration and the partnerships across the organization, which are needed to bring more new, innovative and life-saving products to market quicker.”
Johnson will oversee a global function that includes more than 1,500 scientists, quality professionals and regulatory affairs experts. Catalent’s 300 R&D scientists work across 20 global development teams to develop up to 500 new products at any one time. Catalent’s Quality and Regulatory Affairs teams have helped the company gain accreditation by over 30 global agencies, to supply more than 7,000 products to over 1,000 customers.
Johnson was Catalent’s senior vice president, Global Quality & Regulatory Affairs since 2009, having overseen the roll-out of Catalent’s Global Quality Management system to over 20 global sites. Johnson has 30 years of experience in the pharmaceutical industry, including API and multiple dosages forms, from discovery and launch of NCEs and life cycle management. Previously, Johnson was vice president of quality for GE Healthcare’s Medical Diagnostic Division, having worked in roles of increasing responsibility for Baxter Healthcare and Sanofi Aventis.