**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards **Job Description** Job Summary To ensure that clinical supplies are stored and distributed in accordance with Fisher Clinical Services approved procedures and policies, cGMP, cGDP, and regulatory requirements. Maintain the FCS Japan Quality System in compliance with Fisher Clinical Services approved procedure and policies, cGMP, cGDP, and regulatory requirements. Liaise with clients, internal and external customers on quality related matters. Responsibilities: 1) Ensure the required compliance to relevant internal standards, local and international quality, and regulatory guidelines applicable to Good Manufacturing Practice for clinical trials supply chain activities and drive vital improvements. 2) Maintain a good understanding of local and international regulations, and keeping abreast with regulatory changes and developments. 3) Perform quality activities required by the Quality Management System. This includes scope such as: a) Document control and training management b) Perform pre and post review and approval of production batch records c) Perform pre and post review and approval of label printing records d) In-process check responsibilities for production and label printing jobs e) Management of non-conformances (deviations, complaints and quality investigations) and related corrective and preventive actions f) Responsible for quality compliance of controlled temperature shipments g) Approval of components and material specifications h) Responsible for the release of client/Fisher supplied materials 4) Partner and collaborate to find opportunities and solutions related to regulatory and quality matters impacting the business. 5) Responsible for quality reviews of process performance, product quality and of the Pharmaceutical Quality System and supporting continual improvement. 6) Ensure that a timely and effective communication and escalation process exists to raise quality issues to appropriate levels of management. 7) Perform ad-hoc duties as requested by line management. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.