Editor's note: Recently, Henlius received the Drug GMP Certificate from the NMPA (National Medical Products Administration) for its first product rituximab, also the first biosimilar in China. We got lucky to interview the Vice President of Quality of Henlius, Ms. Cecie Jiang.

Q1 You have a rich working experience in the field of quality management. Could you tell us about the reason why you chose quality work as your career?

Before starting my quality career, I held other positions in the pharmaceutical industry, which included process engineering, analytical chemist, and microbiological researcher. During my tenure in BMS, I transferred to the process engineering department and established a close working relationship with quality management.  This was my first taste of working with a quality unit in the pharmaceutical industry. I enjoyed the interaction with the BMS quality department and became interested in quality.  Later, when I had an opportunity to join Novartis to lead quality compliance investigations, I officially started my career in the field of quality.

I think there are two advantages for working as a quality professional. First, s/he can help a company run efficiently by establishing an effective quality management system. At the same time, quality assurance is the last checkpoint to ensure the quality of the company's products.  As a quality professional, our work directly protects the interests of the patients when it comes to product quality. We‘re not only working for the company, but also represent the patients’ interests. Therefore, I think a quality career is very rewarding and I choose it as the direction of my long-term career development.

Q2 Could you share with us the main reasons for joining Henlius?

To be honest, it took serious and thorough consideration to accept a position to join a local Chinese pharmaceutical company after having been with international pharmaceutical companies (based on the fact that the quality of Chinese products has not reached a leading position in the world). Personally, I first considered whether the company has the right attitude towards quality. A company's quality culture and heritage are very important to me.

I decided to join Henlius for the following reasons:

First, the overall environment of China has truly changed. In recent years, China's drug regulatory agencies have carried out great reform and improved their attention to drug quality, with Chinese quality standards gradually coming into line with those of the global regulatory agencies. The second, Dr. Scott Liu, CEO of Henlius has extensive quality experience and pays great attention to the quality work of the company. He said to me during the interview, "As long as the resource is needed to establish an effective global quality compliance system and ensure high quality products, I will support.” The support from the CEO is the biggest help for my work. Third, with my experience in quality management, I had the urge to return to China and take part in improving the quality of medicines in China. It will also be a great satisfaction for me to help domestic companies establish high standard quality systems and improve the reputation of domestic drugs. At present, there are a limited number of people with a deep understanding of the international quality laws and regulations in China, and domestic pharmaceutical companies really need those professionals in the field.

Q3 In your opinion, how is the quality management of Henlius going? What is the significance of passing inspections for the first product?

The quality system of Henlius has been continuously improving as the company grows and expands. In the early stages of the company, the company was focused on product research and development, then the focus shifted to the clinical research stage, and now Henlius has reached the commercial manufacturing stage, our quality management system has also gone through the same phases. In 2018, Henlius passed the pre-approval inspection of HLX01 and the GMP certification inspection with high standards, meaning that our quality management system has fully met all the commercial manufacturing requirements of NMPA. In addition, the inspectors also commented that Henlius has a strong quality system and we are in a leading position of the quality management systems of the current Chinese pharmaceutical companies.

But Henlius' future goal is to enter the global markets. Only by establishing a quality management system meeting the global regulatory standards, would we have enough confidence to pass the international quality compliance inspections from different countries. As a result of our efforts we will reach our goals and be able to serve the patients all over the world. Most of the management personnel of Henlius have international work experience, so the company has been following the regulations of European and American drug regulatory agencies. Therefore the company's quality system has already incorporated the principles and concepts of the global regulatory agencies. Under the influence of the company's quality culture, the people of Henlius always have a strong quality mindset with "continuous improvement" and keep abreast on the international regulatory guidance and regulations. We are committed to building a world-leading quality management system.

Q4 You have been always busy since joining Henlius, could you share with us the time allocation of your daily life and work?

Thanks to the development of communication technologies, I can easily communicate with my family almost every day. Above all, I need to thank my husband for his support. Since my two children have gone to universities far from home, there is not much difference to communicate with them if I am in the US or China. Of course, it is hard on my husband, but he is always very supportive. Each time I decide to work far away, my husband always supports me as long as he thinks that is good for my career development. He also always encourages me to focus on my job and not to worry about things in the United States. As I don’t have enough time to take care of the family, he has taken most of the responsibility. Last year, our quality team was working on improving our quality system to be ready for the registration application inspection of HLX01, the first product of Henlius and I had no time to go home. My husband told me: "you should focus on your job, and I will come to Shanghai to see you.” He flew to Shanghai to visit me twice. Without his support, I wouldn't have had so much time to pursue my career.

Q5 Combined with your valuable experience, which traits do you think is more important to a quality staff? How about the talent demand of our quality team?

From my personal experience, the people who are really good at quality management have broad experience in different departments other than just quality management experience. It’s better for him/her to work in different departments, especially in the field of manufacturing and quality control. As an example, my process engineering work experience helped me understand the manufacturing process, and my analytical chemist experience helped me understand the quality control activities. The accumulation of these experiences make me well rounded and helps me make better quality decisions. Quality work often requires many different decisions, which may occur in any step of the manufacturing process. Without the extensive experience in the overall drug manufacturing operations, it would be hard to understand the severity of issues and the potential impact to the products. So we prefer people who have experience in different departments of pharmaceutical/biotech companies.

In addition, as a member of our quality team, our values need to be highly consistent with the company's core values of "quality first" and match the company's quality culture. Our quality team has been convinced that only the “Quality First” concept consistently is applied at every step of the drug product lifecycle, we can realize the “the true shortcut”. If we can be right the first in all the steps of the manufacturing operations, we will save time, manufacturing capacity, and manpower. As a result, our drugs will be more affordable to our patients.