Job Details

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.

Key Responsibilities and Major Duties: ​

• Contribute to maintain stable supply of high quality BMSKK products including Cell Therapy products to the market by assisting Quality Assurance Supervisor
• Contribute to perform Quality Control operation (GQP duties) in accordance with Pharmaceutical & Medical Device Act. and other related regulations to work with BMSKK Aichi Plant, contracting manufacturers and BMS internal departments including Global Quality group
• Contribute to maintain/renew BMSKK Marketing Authorization license
• For Cell Therapy products, lead or coordinate to execute market release for commercial and clinical product within the specified time frame, evaluate deviation/OOS/change proposal/CAPA/Product Quality Compliant and promote effectively HA communication
• Facilitate improving Quality Management System in GQP to align with BMS global requirement
• Minimize the risk derived from quality and compliance issues by close communication with internal stakeholders and appropriate negotiation with Health Authority
• Support GMP/GCTP on-site Inspection by Health Authority

Requirements

• More than 10 years pharmaceutical industry with more than 5 years in a quality control and/or quality assurance experience in GQP, GMP/GCTP or GDP operations​

Knowledge:

• PMD Act., GQP/GMP/GCTP ministerial ordinances, and related regulations
• Basic knowledge of DS/DP manufacturing, packaging operation, quality control testing and Japanese Pharmacopoeia
• Create/renew of accreditation for foreign manufacturer, regulatory application for periodical GMP/GCTP compliance inspection etc

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
• 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
• Communication skills in Japanese and English via email and at meetings with overseas in charge person

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/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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.