Manager, Quality Management Systems

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

• The Quality Management Systems Manager is responsible for the managing and maintenance of the Quality Management System. This includes day-to-day support, continuous improvement, and ensuring the consistent implementation of global quality system policies.
• Manages and adheres to Global Quality Management System (QMS) Identifies, triages, escalates and monitors quality issues and investigations across the organization. Elevates serious and/or systemic problems with appropriate recommendations/solutions to Senior Management for immediate and long-term resolution in accordance with Global procedures.
• Proactive ownership of global Quality System procedures (Standard Operating Procedures and Policies such as Change Control, Deviation, Corrective and Preventive Action, Document Management etc. Responsible for the timely completion global compliance, deviation, and CAPA commitments.
• Collaborate with local and global Quality teams to ensure adherence and alignment to global policies, processes and practices. Support the implementation of a single harmonized Quality approach across divisions.
• Responsible for ensuring that the quality management system drives global regulatory compliance, is scalable and appropriate for the organization and product portfolio. Ensures consistency in implementation of global processes, CAPAs, and inspection responses. Manage key quality system projects driving alignment at all levels of the organization
• Experience with drug development and/or commercial Quality systems focused on the development, manufacture and delivery of small molecule, biologic and advanced (gene) therapy IMP. Leads risk assessment and mitigation activities to establish and improve the Quality Management System. The candidate works cross functionally to align the approach to quality and compliance across the global organization.
• Expertise in the areas of responsibility with technical and personnel leadership qualities, including GxP acumen aligned with industry best practices. Partners with clinical and/or commercial operations and across organization to streamline and continuously improve Quality systems, ensuring compliance with regulatory requirements.
• As needed, partner to support audits and inspections with the goal of compliance to regulations and global harmonization. Support identification and implementation of new regulations and Quality trends within the Pharmaceutical industry through literature review, professional conferences, and benchmarking organizations.

• Responsible for supporting all aspects of the Quality Management System to support standards, procedures and compliance. Local and global responsibility for the day to day management of process effectiveness and where gaps are identified; proactively elevate to Senior Leadership, propose and implement solutions to ensure compliance.
• Proactive oversight of the Quality System (process, systems and procedures) to facilitate ongoing pharmaceutical development activities for adherence to the current regulations and industry best practices. Champion an environment of transparency and continuous improvement in managing and implementation of Quality Process and Procedures
• Drive and foster a Quality Mindset across the organization and work with relevant stakeholders to implement a Quality Culture focused on delivery of results as it pertains to focused deliverables within the functions and to the stakeholders

• Collaborate with the functional representatives within DSI and globally within the DSG network to align processes and procedures as they pertain to how the organization executes work and ensure alignment with industry regulations and best practices
• Partner with local and global functions to provide guidance and oversight of specific processes. As part of global support, ensure cross-functional alignment and overall applicability across…