As QA manager you will manage the Quality Assurance department, oversee the daily activities and do the planning of both operative and improvement-related activities. You are responsible for people management activities with regard to the QA team, and act as direct point of contact with clients to manage quality topics such as quality agreements with clients, and lead preparatory activities towards client audits and regulatory inspections in close corporation with the QPs. Moreover, the role entails: Leading complex change control proposals and investigations in quality records; Identify the need for quality improvement/lean projects and enroll team members in implementation; Ensure that the identified improvement/lean projects are executed; Implementing GMP guidelines into quality procedures for continuous improvement of the QMS; Translate guidelines and regulations into daily practice; Advise and review documents for raw material selection, master batch records, analytical methods, including assay validations; Advise and participate in projects related to facility and equipment design, change proposals, URS preparation and C&Q documentation; Advise on design of process validations including: cleaning validation, sterilisation validation, media fills and decontamination processes of clean rooms; Develop and provide training on quality topics with QA department as well as within the organisation.