RISK MANAGEMENT

Quality means “fitness for purpose”, with a degree of flexibility allowed and even encouraged by regulators (e.g. ICHQ9) as to how compliance can be achieved. Within the Quality Risk Management (QRM) project in 2008, the concept of Quality Risk Management was introduced within the global audit team through interactive training, practical tools and gradual integration of QRM into essential processes. This resulted in a more targeted audit program and more efficient, leaner business processes that still meet requirements. As a side effect, QRM created a common communication platform between quality and business employees, leading to more effective collaboration.

Christel has played a key role in achieving and maximizing success for the QRM project. She has a unique set of skills that allows her to involve people in change projects and make steady and structured progress, even in a very complex environment. Her enthusiasm and communication skills stand out; both written and verbal, she combines professionalism and creativity in a balanced way. Furthermore, she has strong determination, a “can-do" mentality and resilience. She approaches challenges and complex matter in a structured and step-by-step manner, taking into account both cultural and process aspects.

Anja Gilis, Director of Nonclinical Compliance, DPDS @ J&J Innovative Medicine