The Associate Director Quality – Client Dedicated Process & QD Manager performs various activities in support of process elaboration, design/mapping, documentation (controlled documents and managed information documents) development, review, formatting, and revision for GDO. Support focuses on ensuring that good process design principles and appropriate documentation standards are consistently applied, that activities are consistently and efficiently coordinated and that deliverables are completed in a high quality and timely manner. Support may also be provided to coordinate audits and audit response processes and to ensure compliance with agreed CAPA due dates, as needed. In addition, the Process & QD Manager is in charge of coordinating GDO training assignments, Managed Information and cross-functional QD reviews (incl. representation of GDO in DEC).