The Quality Assurance Unit is essential in ensuring the reliability of pharmaceuticals throughout their lifecycle, from research and development to manufacturing and sales. By emphasizing quality, the unit supports the provision of high-quality pharmaceuticals that comply with global standards. This article examines the significance of quality assurance work through the perspectives of three young employees on the frontlines of quality assurance.

*Reprinted from Chugai's official talentbook (https://www.talent-book.jp/chugai-pharm). The descriptions and affiliations are current as of December 2024.

The "Last Line of Defense" Protecting Pharmaceutical Reliability: Supporting Quality Through Four Quality Dimensions

The Quality Assurance Unit ensures the quality and safety of pharmaceuticals. Throughout their lifecycle, from research and development to manufacturing and sales, the unit practices quality management grounded in regulatory science, contributing to the assurance of reliability.

 

Tokiwa　"The Quality Assurance Unit focuses on four dimensions of quality to enhance pharmaceutical reliability: 'product quality,' 'information quality,' 'process quality,' and 'human resource quality.' The unit comprises five departments: Quality Assurance Planning, Quality Assurance, Regulatory Management, Quality Promotion, and Medical Information Assurance. In the Quality Promotion Department, where I work, we lead quality improvement efforts and strengthen quality management through activities such as auditing, deviation management, and process evaluation and improvement, while overseeing regulatory areas like NCP, GLP, GCP, and PV/GVP. Within the department, the Global QA Strategy Promotion Group, where I belong, primarily handles audits in clinical (GCP) and safety (GVP/GPSP) areas and responds to regulatory authority conformity inspections when introducing pharmaceuticals to market."

Kuwahara　"The Quality Assurance Department ensures compliance with both domestic and international regulations governing manufacturing and sales. Our goal is to maintain and enhance quality from investigational drugs to marketed products, delivering high-quality products to patients. The Customer Communication Group, where I work, responds to inquiries from medical institutions regarding pharmaceutical quality, based on the 'Ministerial Ordinance on Standards for Quality Control of Pharmaceuticals, Quasi-drugs, Cosmetics, and Regenerative Medical Products (GQP).' We investigate causes and prepare responses to customer inquiries. Under Chugai Pharmaceutical's core value of 'patient-centricity,' our mission is to use these inquiries as opportunities for improvement and collaborate with sales, production, and research departments to provide more reliable products."

Shoji　"The Regulatory Management Department oversees the company's regulatory intelligence activities based on pharmaceutical regulations. It leads post-marketing regulatory responses and ensures the appropriateness of quality control for pharmaceuticals, medical devices, and regenerative medicine, as well as managing and maintaining business licenses under the Pharmaceuticals and Medical Devices Act. In the Regulatory Governance Group, where I work, we maintain necessary business licenses for Chugai Pharmaceutical's operations. Business licenses must be renewed every five to six years, during which regulatory authorities conduct inspections to confirm that the company fulfills its responsibilities. Our role includes managing notifications, communications with authorities, and maintaining procedural documentation. Our mission is to deliver products of assured quality, efficacy, and safety to patients, while coordinating with relevant departments when concerns arise."

Three Missions on the Frontlines of Quality Assurance: Different Perspectives, Different Fulfillment

Establishing a global quality assurance system and achieving consistent quality control demands rigorous processes and rules. However, Tokiwa emphasizes the need for flexibility to accommodate field operations and external partners.

Tokiwa　"If we reject inquiries from operations with the response 'regulations don't allow it,' we complicate the work for those in the field. One of our responsibilities is to find optimal solutions within established rules. I was particularly impressed when we responded to a regulatory authority’s conformity inspection regarding the reliability of clinical trials for a product introduced by an overseas pharmaceutical company. We collaborated with licensing partners and their contracted companies. Although we faced language and cultural barriers, we held weekly meetings and consistently coordinated by explaining Japanese regulations and presenting countermeasures. Ultimately, we overcame these challenges successfully, which led to significant personal growth and a sense of fulfillment."

Kuwahara notes that quality assurance often involves delicate handling. She finds great satisfaction in solving problems as a team.

Kuwahara　"Quality assurance is never a solitary job; it requires collaboration with multiple stakeholders. Investigating quality information involves communicating with manufacturing sites, including those of other companies, and coordinating with MRs who respond to inquiries from medical institutions. Rather than imposing requirements unilaterally, effective communication is essential to ensure alignment. Receiving feedback from medical institutions such as 'Thank you for your prompt response' or 'Chugai Pharmaceutical is indeed reliable' after our sincere efforts is highly encouraging."

Shoji, whose focus is pharmaceutical regulatory responses, views her role as one that proactively proposes methods for compliance rather than simply following regulations.

Shoji　"When new regulations or legal amendments emerge, we must establish new rules for the company to follow. Since different departments have various methods and ideas, finding solutions that satisfy everyone is challenging. For me, incorporating new elements and developing systems for the company is a difficult but rewarding task. For instance, I am currently working on compliance with biodiversity regulations for our company's first gene therapy product. This is a novel challenge, but I find fulfillment in helping create systems that give patients greater peace of mind."

Although each individual works in a different area, their motivations are rooted in a shared commitment to quality.

Tokiwa　"I became interested in the Quality Assurance Unit because I believed I could engage with people from diverse departments and acquire multifaceted knowledge about product lifecycles. Sharing common goals with others and celebrating collective achievements drives my motivation."

Kuwahara　"Considering better operational methods to comply with regulations is an important part of our role. Through these efforts, delivering higher-quality products to patients is both our goal and motivation."

Shoji　"Regulatory responses are a field where outcomes are not always immediately visible. However, when we receive feedback from the field saying 'It's easier to work now' or 'This method was optimal' after revising rules, it is highly motivating. The joy of achieving goals as a team with related departments also fuels my motivation."

Growth Fostered by a Culture That Encourages Challenges and Flexible Work Styles

All three employees joined Chugai Pharmaceutical as recent graduates and have shared their experiences of the company from their respective perspectives.

Tokiwa　"I find that many compassionate individuals work at this company. Most have a cooperative attitude, and when I ask, 'Do you have a moment?' they readily agree to help, which makes me appreciate the people and the comfortable work environment."

Kuwahara　"The opportunity to challenge myself in diverse areas is highly appealing not only in pharmaceuticals but also in fields such as digital technology, quality assurance for medical devices, and regenerative medical products, areas in which Chugai Pharmaceutical has not previously been involved. Thanks to the positive environment, I look forward to work every day."

Shoji　"I previously proposed an efficiency measure using digital technology, which was accepted and implemented. I’m drawn to the company culture, where even young employees can easily voice their opinions and take on new challenges. There’s also a comprehensive training system for new graduates, and career-hired employees seem to integrate quickly through the mentor system. I believe the company offers an environment where both new graduates and mid-career hires can thrive and showcase their strengths."

Flexible work arrangements are another common attraction mentioned by all three employees.

Tokiwa　"Working from home is the primary arrangement, with the principle of coming to the office at least once a week. This allows us to adopt a hybrid work style, handling tasks online when feasible and coming to the office for more efficient face-to-face discussions."

Kuwahara　"I typically come to the office 2-3 times a week, balancing office and online work in a hybrid manner. I feel that this environment enables the realization of flexible work styles."

Shoji　"I agree. I think we can work using various approaches: face-to-face for collaborative brainstorming and from home for focused tasks. The flexibility of work styles is very high."

Evolving Rules and Pursuing Quality: Continuing to Provide High-Quality Products to Patients

Tokiwa　"We have numerous opportunities to interact with various departments, and strong communication skills, especially the ability to collaborate across departments, are essential. A spirit of challenge is also important. We welcome individuals with initiative, who seek improvements, propose solutions, and volunteer for new tasks."

Shoji　"This workplace is ideal for those who can understand the essence of regulatory requirements and drive change. Additionally, we are tasked with explaining company rules to various departments and establishing systems to ensure compliance. Simply stating 'because it's a rule' is not sufficient. I believe those who can listen to different perspectives, understand them, and articulate them clearly can excel."

Kuwahara　"Collaboration across departments is crucial to ensuring quality. In addition to communication skills, personal credibility is necessary—people should trust someone and believe, 'If this person says so, it must be true.' We seek individuals who can understand others' perspectives and work together toward shared goals."

All three employees also aim to continue challenging themselves with new goals.

Tokiwa　"In the future, I hope to take on an overseas assignment and contribute to overseas audit activities and QA operations. I want to develop the ability to adapt to different regulatory environments and mindsets. A concept that has resonated with me since joining the company is 'quality culture,' which refers to the mindset that prioritizes quality as the foundation for excellent products. I hope to promote this within the company, the industry, and beyond."

Kuwahara　"Currently, I primarily handle quality-related information within quality assurance operations. I aim to gain broader experience and develop into a well-rounded quality assurance professional who can contribute to quality assurance across the entire product lifecycle. I am also interested in 'quality culture,' a concept that emerged as industry regulations tightened, though it still lacks a definitive framework. I aim to help Chugai Pharmaceutical shape and communicate this concept."

Shoji　"My goal is to become someone who is trusted for regulatory interpretations. To achieve this, I believe I need to expand my knowledge and gain diverse experiences. I want to challenge myself with new tasks and broaden my expertise. Regarding quality culture, when I previously participated in a quality awareness initiative within the Quality Assurance Unit, I realized that other departments view quality from various perspectives. I hope to increase opportunities to discuss quality and contribute to its dissemination."