Deliver "high-quality" and "peace of mind" for patients around the world as a quality assurance specialist.

Quality assurance position

2006—Entered the Company after graduating from the Department of Applied Chemistry, Faculty of Science and Technology

Involving in post-market quality assurance utilizing the knowledge cultivated during the research career

"To deliver drugs that can be used safely by patients around the world." Our department is responsible for the mission of ensuring the quality of drugs developed and marketed by Mitsubishi Tanabe Pharma, and I`m in charge of quality assurance of post-marketing drugs which is specifically responsible for managing the appropriate implementation of manufacturing and quality control in accordance with laws and regulations at pharmaceutical manufacturing plants. When we start producing a new drug, we will establish a quality assurance system based on strict standards, and if a quality-related defect occurs in the manufacturing process, we will investigate the cause and make improvements. It is also important to respond to inquiries about quality from patients and medical institutions. It is rewarding to be involved in the pharmaceutical industry in such a position which is very close to the patient.

Our department has members with various backgrounds. When I joined the company, I was assigned to the field of drug discovery research. I was involved in chemical synthesis research with a focus on small molecules for 13 years. Although it was a different field from quality assurance, I worked every day to enhance my expertise in my current field while making use of the knowledge and experience I have cultivated as a researcher.

Working in US for 2 years, which led to my new growth.

I was stationed in the United States for two years from 2022. My main job was to supervise the quality assurance team which manages manufacturers for packaging supplied drugs manufactured in Japan. I needed to work with sales and logistics teams since the number of staff was limited and the scope of my responsibility was wide.

At that time, there was a new drug that was selling well in the U.S., and a defect in the manufacturing process threatened to affect the supply. I analyzed past manufacturing data, made fundamental improvement proposals, and developed more detailed schedule to determine the cause, and I was able to deal with the problem without disrupting supply.

Taking on the challenge overseas was a career step that I wished. I did struggle sometime within a different environment, but I was able to learn a lot of things, such as how to manage quality from a global perspective and how to communicate with respect for others, and I think it was a valuable experience that led to new growth for me.

Delivering high-quality medicines imagining your family in use

Mitsubishi Tanabe Pharma is supplying drugs in Japan and overseas. In addition, we are expanding our manufacturing bases not only in Japan but also overseas. As a result, in recent years, the ratio of work with overseas affiliates has increased, and there are more opportunities to travel overseas. The environment related to quality assurance is diversifying, and I feel that the scope of responsibility we should fulfill is expanding more and more.

Long time ago, my grandmother told me, "I feel better because of your company's medicine." Since then, when I am worried about work, I am conscious of delivering high-quality medicines to the market imagining that my family will use them.

The modalities of new drugs are also diversifying. Recently, I have been attending external seminars on biopharmaceuticals to broaden my expertise. I am also working on improving my English in order to hone my skills. I would like to enhance my capabilities as a quality assurance specialist to deliver high-quality drugs unique to Mitsubishi Tanabe Pharma to patients around the world.

Career step: 2006 Assigned to the Drug Discovery Research Laboratory and worked as a chemical synthesis researcher
2019 Transferred to the Global QA Department of QV Division and get involved in post-marketing quality assurance
2022 Assigned to Mitsubishi Tanabe Pharma America (MTPA) and worked there for 2 years
2024 Promoting quality assurance work globally after returning from MTPA

* The affiliation and description in the article are those at the time of interview.