**Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. 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. Read more: careers.bms.com/working-with-us . **High-level Description** Senior manager, Quality Assurance (QA) is responsible for managing and leading Quality Assurance activities, and for ensuring that all processes/activities at Aichi plant are in compliance with regulatory and corporate policies and that manufacturing and testing activities are carried out in accordance with cGMPs (current Good Manufacturing Practices)appropriately. **Roles & responsibilities** + **Operate and manage the QA Operation team.** - Understand the company ' s and department ' s policies and set team goals. - Coach team members and implement performance management to achieve set goals. - Allocate resources to maximize team performance. - Implement effective development strategies to achieve high - performance teams. - Lead, operate, and manage the team through effective communication. - Promote resource planning and improvement activities. + **Maintain product quality and comply with laws and regulations through the following processes:** - Monitor the entire production process and ensure that its activities are GMP compliant. - Conduct deviation investigations, impact assessments, and make decisions on product quality in deviation management. Lead adherence to deadlines for required improvement actions. - Maintain, manage, and improve the market complaint investigation process, including quality information. Assess the impact on product quality and plan necessary actions. - Operate the Quality Risk Management assessments / program and oversee quality risk management in the Aichi Plant process. - Check the status of manufacturing control and quality control, etc., and decide whether or not to ship from the factory. Confirm SCM, IP, and QC information on production and shipment schedules, and manage shipment decisions within the deadline. - Establish and maintain good relationships with domestic and overseas contract manufacturers, including overseas BMS factories that supply intermediate products to the Aichi Plant, as well as the External Manufacturing Division, to ensure smooth communication regarding quality and to effectively implement improvements in quality problems. Maintain close communication with domestic and overseas material suppliers who supply materials to the Aichi Plant, and appropriately improve quality problems. - Escalate Quality concerns to the Director of Quality for Aichi Operations + **International work** - Working with director, participates as a stakeholder and member of the Global Commercial Manufacturing Operation team that develops and implements distribution strategy for BMS Network organization. + **Act as the primary delegate for the Director of Quality at Aichi when a delegate is required.** **Required knowledge/ Skills** Bachelor' s degree required, preferably in science, pharmaceutics, or other related technical discipline. A master's degree is highly desirable. -Understanding of technical areas related to pharmaceutical manufacturing, statistical methods, quality control, and quality assurance. -Strong understanding/knowledge of cGMPs, GQP and regulatory requirements -Knowledge and demonstrated ability to analyze and solve complex problems. Ability to effectively communicate visions/ideas and persuade others to accomplish challenging goals and objectives. -Must have a demonstrated ability to plan, implement, and achieve significant, complex goals and objectives. -Demonstrated ability to work with and manage people in a complex, changing environment to deliver value added results to the organization. -The ability to work with a wide range of technically and culturally diverse people is important. -Fluency in Japanese and English is required. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. **Uniquely Interesting Work, Life-changing Careers** With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. **On-site Protocol** BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. **Company:** Bristol-Myers Squibb **Req Number:** R1585878 **Updated:** 2024-11-13 03:12:21.818 UTC **Location:** Aichi-JP Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.