Manager, GDP Lead of 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 GQP, GDP and GMP tasks as a shared function. •Responsibile for enforcing appropriate GQP/GDP operation in accordance with Pharmaceutical & Medical Device Act., GQP/GDP guideline and other related regulations. •Contribute to the maintenance and management of BMSKK's wholesale distribution business license. •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 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 appropriately, and contribute in order to execute the activities properly. •In order to ensure the safety and stable supply of BMSKK products, rovide timely and appropriate support from the viewpoint of safety management and quality assurance onto operations that the SOKATSU should perform. •Assist the senior manager in contributing to BMSKK's business through stakeholder management and risk management. 【Position Responsibilities】 •Sufficiently and timely, understand the J-PAL and any other regulations related to products quality assurance, and coordinate and lead the stakeholders so that matters that need to be addressed as BMSKKK 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. •Assure product quality during the course of distribution in compliance with the GQP/GDP guidelines •Maintain and manage BMSKK's wholesale distribution business license. •Improve the quality system and product quality continually through management review. •Build and maintain a close relationship of trust with global quality, and build and maintain processes aligned with the global quality management system. •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 quality issues / deviations that occurred, 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 meetings with the three responsible persons on GXP, and create and save accurate minutes. •Facilitate inspections and investigations executed based on regulations related to quality assurance, and provide appropriate support so that the people can respond appropriately to indications from the competent authorities. •Involving the business alliance partners (Ono Pharmaceutical, Pfizer Pharmaceuticals, Mitsui etc.) and internal and external stakeholders, plan and execute mock recall of products after release, and lead people to perform the necessary actions (revision of procedures, addition of R & R of personnel in charge, etc.). •In accordance with product-specific strategies and related laws and regulations such as GQP, GDP and GMP, and internal business procedures (GQP-SOP, GDP-SOP and Global SOP), provide high-quality materials which are fully conscious of customer satisfaction. •In order to manage the budget appropriately, make a proposal for the short-term/long-term budget plan and review them. Coordinate to make the draft budget plan with each departments, and obtain the approval from Head of department. Then, propose the budget plan to GRSB Finance. Moreover, check the budget implementation of the department each, and conduct the periodical review. •Maintain and manage the business continuity plan (BCP) in the department 【Degree Requirements】 •University Bachelor of Science or Master of Science in Science •It is desirable to have a pharmacist license 【Experience Requirements】 •More than 3 years of experience in GQP, GDP or GMP related work •Cross-organizational project lead experience 【Key Competency Requirements】 ◆Knowledge •Knowledge of GQP/GDP/GMP ministerial ordinance and notification of enforcement of these ministerial ordinances. •Fully understanding of the J-PAL and related regulations, the Japanese Pharmacopoeia, and life cycle management of medicine (approval, change, succession, approval arrangement, etc.). •Knowledge of change control of package inserts and other legally labeling for products ◆Skills •Communication / negotiation skills to build good relationships with regulators and relevant departments. •Strong leadership to drive cross-functional tasks. •Logical thinking to develop management strategies. •General project management skills, including problem solving. •Ability to propose problem solutions related to safety management and quality assurance. •Ability to propose measures to minimize business impact on risks related to the stable supply of products. ◆Language skills •Be able to communicate with overseas representatives through meetings and e-mail •Have ability to understand English materials related to work Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.