Manager, Safety & Quality Management Office

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. ■Position Summary Contribute to improving the quality of GVP, GQP, and GPSP tasks as a shared function. In order to ensure the safety and stable supply of BMSKK products, Provide timely and appropriate support from the viewpoint of safety management and quality assurance onto operations that the SOKATSU should perform. Work closely with internal and external stakeholders with a focus on customer satisfaction, and promote proper use of marketed products by providing strategic activities related to safety management and quality assurance, high-quality materials and accurate proposals. To ensure compliance as a pharmaceutical manufacturer and distributor, fully understand the relevant laws and regulations and contribute to maintaining the MAH license. Manage the budget of PA&PV appropriately, and contribute for PA&PV in order to execute the activities properly. Assist the senior manager in contributing to BMSKK's business through stakeholder management and risk management. Sufficiently and timely, understand the J-PAL and any other regulations related to safety management and products quality assurance, and coordinate and lead the stakeholders so that matters that need to be addressed as BMSKKK_PA & PV can be implemented without delay until completion. In order to ensure compliance as a MAH and improve the quality of tasks, execute the self-inspection according to GXP ordinances and confirm compliance status for J-PAL and internal GXP-SOP, and provide advice which is based on regulations to people in charge if necessary. In the outsourcing business, lead to conclude appropriate contracts in accordance with the relevant laws and regulations, and supervise work performance by the trustees so that the outsourcing business will be performed appropriately in accordance with the SOPs provided by BMSKK. For the safety and quality issues / deviations that occurred in PA & PV, conduct an accurate cause analysis to minimize the risk to the business, and manage and support people in charge about planning and executing strategic CAPA. Based on J-PAL and regulations, properly manage change control including renewals of licenses related pharmaceutical businesses and lead negotiations with competent authorities as necessary. Properly set up and facilitate information sharing meetings with the four responsible persons on GXP (including GPSP), and create and save accurate minutes. Facilitate inspections and investigations executed based on regulations related to safety management, quality assurance, and re-examination, and provide appropriate support so that the people in charge at PA & PV department can respond appropriately to indications from the competent authorities. Involving the business alliance partners (Ono Pharmaceutical, Pfizer Pharmaceuticals, etc.) and internal and external stakeholders, plan and execute mock recall of products after release, and lead people in charge at PA&PV department to perform the necessary actions (revision of procedures, addition of R & R of personnel in charge, etc.). In addition to ensuring for re-examination submission is properly prepared, plan and coordinate the conformity audits conducted by PMDA, prepare for the GPSP conformity audit and respond on the day, and support creation and submission the despondence accurately to inquiries. In accordance with product-specific strategies and related laws and regulations such as GQP and GVP, and internal business procedures (GQP-SOP, GVP-SOP, Global SOP), provide high-quality materials which are fully conscious of customer satisfaction. (examples are described below)　 Notification letter on revision in safety of package insert Guidance for patient using its products Safety information posted on the BMSKK /PMDA website for health Plan and report of EPPV Notification the result of re-examination applications In addition to coordinating related documents (IPVCD, etc.) within the department so that they align with the Global PV department (WWPS), by execution