The responsibilities encompass a wide range of tasks, including serving as the primary liaison with clients to manage quality matters and managing quality agreements. Internally, the role involves leading QA colleagues in project teams, providing guidance on regulations, leading change control initiatives, and advising on various aspects, from raw material selection to process validations. Additionally, the role includes hosting client audits, external auditing of service providers and suppliers, maintaining auditing programs, and serving as the focal point for regulatory authorities. It also entails batch disposition and certification in compliance with EU/FDA directives and handling Product Quality Complaint investigations and product recalls.