.The Role: The Senior Manager of Quality Assurance Disposition, Deputy Qualified Person for Moderna's International Organization will act as Deputy Qualified Person in accordance with EU GMP to provide final certification/release along with ensuring overall maintenance of site quality management system (QMS) to support release of product for EU/EEA markets as well as wholesale distribution to EU countries. The Deputy QP will perform audits of third-party providers, suppliers, and contract manufacturing and testing organizations in order to ensure EU GMP standards have been achieved and will support the internal audit program to enable permanent inspection readiness.This Deputy QP Role will also provide QP GMP declarations in support of importation activities and will be expected to maintain up to date awareness of regulatory issues and international regulatory requirements. This role will work cross-functionally to create and maintain standards for GXP compliance and will have a high degree of impact across the organization. The incumbent will provide QP support during weekends.Here's What You'll DoExecute, according to a written delegation, QP responsibilities, duties, batch certification and disposition for products in the EU as defined in EU Council Directives and Eudralex Volume 4, Annex 16.Ensure products are manufactured in accordance with cGMPs, internal policies/procedures and applicable regulatory requirements and guidance.Maintain thorough and up to date understanding of international regulatory requirements and guidance.Take actions necessary to maintain and extend technical and professional competence in support of QP responsibilities and ensure thorough understanding of any products and processes prior to conducting any QP batch certification and disposition.Understand and support review of investigations, root cause analysis and review and approval of major/critical deviations, complaints and change controls with process and product impact.Support Quality Systems and Compliance on continuous improvement of the Quality Management System (QMS), support quality management review processes, annual product quality reviews, overall inspection readiness and state of control.Establish and maintain effective communication with clients to match internal and external expectations.Interact with Health authorities as it pertains to Moderna's licenses and regulatory activities.Act as contact person for product defects and recalls for EMA and support recall of product if needed.Provide QP GMP declarations in support of regulatory filings and assist in maintaining GMP/GDP regulatory licenses.Perform QP Audits internally and externally of suppliers and contract testing and contract manufacturing organizations and support health authority inspections