Senior Manager, Quality Compliance Lead

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 Responsibilities Support Quality Assurance Supervisor for the product release(not only commercial Drug Product but also CAR T commercial/investigational products) to market by the proper evaluation for production control and quality control. Plan and execute the CAPAs for quality improvements and deviations by analyzing the information related to the product quality. Execute following tasks appropriately: Evaluate and confirm the changes the manufacturing processes and the test methods; Evaluate and handle the deviations during manufacturing; At product recall, prepare and file the reports to the authority and records/documents related; Appropriately manage to fulfil the requirements of Pharmaceutical & Medical Device Act. and other related regulations. Manage not to occur discrepancies between the contents in the approved file (site information, manufacturing processes, testing items and other necessary information) and the actual manufacturing site. Create of GMP/GCTP inspection application and response to PMDA queries. Coordinate GMP/GCTP on-site Inspection by Health Authority. Generate labels for commercial products and CAR T investigational products in accordance with Pharmaceutical & Medical Device Act. And other requlations. Build and maintain a close relationship of trust with global quality, and build and maintain processes aligned with the global quality management system. Share knowledge and provide guidance to the members within the Quality Assurance Department, and promote the enhancement. Experience Requirements · Minimum 5+ years of experiences in GQP, GMP/GCTP or GDP operations · Minimum 3+ years of experiences in managed organization and and working closely with the global team · Experience of leading on cross functional project management Key Competency Requirements Knowledge: Knowledge of PMD Act., GQP/GMP/GCTP ministerial ordinances, and related regulations. Basic knowledge of DS/DP manufacturing, packaging operation, quality control testing and Japanese Pharmacopoeia. Knowledge of accreditation/renew of accreditation for foreign manufacturer, regulatory application for periodical GMP/GCTP compliance inspection etc. Skill: Communication skill for achieving good relationship with authorities and connected departments. Strong leadership skill to perform cross functional tasks. Logical thinking to make regulatory strategy. (Technical Skill) Managing and supervising skill for appropriate manufacturing and quality control of the manufacturing sites (API site, Formulation site, etc.) listed in approved files. Capabilities of analyzing the management results of manufacturing sites, make instructions for improvement if necessary. Skill to negotiate with PMDA officer on regulatory application and inquires Language skills: · Communication skills in English via email and at meetings with overseas in charge person. Travel Required Domestic and occasional International travel are required. Travel to manufacturing site in foreign country, 1 -2 weeks each trip, 1-2/year. 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.