藥明康德如何能始終做到高質(zhì)量交付？他說“真金就要經(jīng)得起千錘百煉” | 逐夢者說 | Bilingual

編者按：“讓天下沒有難做的藥，難治的病”，是初心，更是愿景。自成立以來，藥明康德步履不停：從一間實驗室，到覆蓋亞洲、歐洲和北美的全球網(wǎng)絡(luò)。從早期的化學合成服務(wù)，到貫穿研究（R）、開發(fā)（D）和生產(chǎn)（M）的一體化平臺。從第一位客戶，到全球三十多個國家的數(shù)千合作伙伴。不斷發(fā)展的，是規(guī)模與能力；始終堅守的，是夢想與承諾。

致敬來時路，共譜新篇章！在這一系列訪談中，我們以“逐夢者”視角，回顧藥明康德成長發(fā)展的崢嶸歲月，回望賦能客戶創(chuàng)新的并肩往事，更以獨特的“藥明精神”展望未來新篇章。

每到周末，當郵件減少，辦公室燈光漸暗，德克·托曼斯（Dirk Tormans）常會尋一處靜謐之地獨自散步。

不管是走在蜿蜒的公園小徑里，還是走在開闊的河畔步道上，對他來說既是難得的放松方式，也是換一種心情思考問題的寶貴機會。

經(jīng)常是走著走著，縈繞在心中的問題就會迎刃而解，對未來的各種設(shè)想也涌上心頭。

不散步的時候，德克會在電腦上玩策略游戲。他坦誠地笑了笑說，這個愛好在很多方面都與他在工作中秉持的理念不謀而合——兩者都需要總覽全局、關(guān)注細節(jié)、預(yù)判風險、見招拆招、有勇有謀地采取行動，并從經(jīng)驗中不斷學習。

回望德克30年來的職業(yè)生涯，他的工作內(nèi)容基本離不開這九個字——質(zhì)量管理與質(zhì)量控制。

在醫(yī)藥行業(yè)，質(zhì)量尤其具有不可撼動的地位，既是企業(yè)長遠穩(wěn)健發(fā)展的根基，更是關(guān)乎患者健康安全的“生命線”。

而“高質(zhì)量交付”之所以能成為藥明康德的一張名片，背后是藥明康德質(zhì)量管理團隊對上述工作理念長年累月的傳承與堅守，以及由此打造出的一套高標準、成熟龐大并不斷完善的質(zhì)量體系。

圖片來源：123RF

自成立以來，這套堅實的質(zhì)量體系已深深根植于藥明康德全球各個基地的土壤之中，守護著世界各地數(shù)千家創(chuàng)新者的新療法從萌芽到開花結(jié)果、來到患者身邊。

每一天，高標準已成習慣

作為藥明康德化學業(yè)務(wù)平臺全球質(zhì)量保證（QA）負責人，用德克自己的話說，他的角色“就像是質(zhì)量的推動者”。

他經(jīng)常向團隊強調(diào)的一句話是，質(zhì)量管理不能只在有人監(jiān)督時才去執(zhí)行，不能因為會有檢查才去準備，而是要自發(fā)融入每一天的日常工作習慣。

談到這一點，他回想起了藥明康德在去年經(jīng)歷的一次檢查。

那是一個早晨，在沒有事先通知、毫無準備時間的情況下，美國食品藥品監(jiān)督管理局（FDA）的檢查人員突然造訪了藥明康德的一家生產(chǎn)基地，并開始了質(zhì)量審查。

在業(yè)內(nèi)，這種不預(yù)先告知的突擊檢查方式被稱為“飛行檢查”（簡稱“飛檢”），是監(jiān)管機構(gòu)為確保藥品在研制、生產(chǎn)、經(jīng)營、使用等環(huán)節(jié)符合質(zhì)量管理規(guī)范的常見做法，從而保障藥品質(zhì)量、保護公眾健康。

在檢查過程中，當?shù)貓F隊并沒有暫停手頭的任務(wù)，也沒有為了應(yīng)對檢查臨時進行特別的調(diào)整，而是一如既往地按照既定流程工作著。

之后，檢查順利結(jié)束，F(xiàn)DA未發(fā)現(xiàn)任何不符合項。這驗證了一個事實——藥明康德能順利地通過檢查，不是靠“臨陣磨槍”的準備就能做到的，而是因為每一天的日常工作都經(jīng)得起檢驗。

以往的記錄也證明了這一點。僅在2024年，藥明康德就接受了各類質(zhì)量審計共計802次，包括69次來自監(jiān)管機構(gòu)的審計、719次來自全球客戶的審計，以及14次來自獨立第三方的審計；就在2025年3月，常州及泰興的兩個原料藥基地相繼成功通過美國FDA檢查。

回望藥明康德的來時路，你會發(fā)現(xiàn)，從創(chuàng)立伊始，藥明康德就嚴格遵循來自客戶和監(jiān)管部門的高標準、嚴要求，通過了來自美國、歐盟、中國、日本、瑞士、澳大利亞、加拿大、新西蘭等國家地區(qū)監(jiān)管機構(gòu)的數(shù)百次審計。

在德克看來，這些“零缺陷”、“全通過”的記錄，不是靠“救火隊員”的力挽狂瀾，而是靠每一個成員都將高標準、嚴要求銘記在心，將這個習慣滲透到投料控制、實驗記錄保存、偏差處理等日常操作的方方面面。

以藥明康德的化學業(yè)務(wù)為例，從原料的資質(zhì)認證、供應(yīng)商管理，到生產(chǎn)執(zhí)行、設(shè)備校驗，再到分析驗證、包裝、存儲和運輸全流程，公司早已建立起了一個系統(tǒng)化、結(jié)構(gòu)化的質(zhì)量體系。

德克指出，這個質(zhì)量體系之所以能不斷完善，不只是靠QA團隊對流程的推動，更依賴于各業(yè)務(wù)團隊每一位同事的智慧與汗水。

他經(jīng)常向大家強調(diào)，“全員都是質(zhì)量的責任人，為保障患者的安全，從高層管理人員到每一個執(zhí)行環(huán)節(jié)的同事，都要共同遵守質(zhì)量體系、共同守護對客戶的質(zhì)量承諾”。

圖片來源：123RF

德克還特別提到了一點：自成立以來，藥明康德從來沒有因質(zhì)量問題經(jīng)歷過一次重大監(jiān)管投訴或執(zhí)法行動，也沒有卷入過一次召回事件。

說到這里，德克百感交集，因為他深知要做到這樣有多難，更清楚失守的危害有多大——一旦出現(xiàn)質(zhì)量問題，就可能造成藥品供應(yīng)中斷或短缺，最終受到?jīng)_擊的還是患者。

尤其對于一些重癥患者而言，失去了一款為數(shù)不多的有效藥物，就可能失去了延續(xù)生命的機會。

在這一背景下，藥明康德自成立以來，始終保持著良好的記錄，既是對技術(shù)與誠信兼顧并重的自我約束，更是對患者生命健康的珍視與守護。

每一個基地，高質(zhì)量始終如一

德克表示，藥明康德為客戶提供高質(zhì)量服務(wù)的承諾，不僅僅是時間上的“每天始終如一”，還在于空間上的“每個基地都始終如一”。

自成立以來，為了更好地為當?shù)睾腿蚩蛻籼峁╈`活、高效和高質(zhì)量的賦能服務(wù)，藥明康德的全球發(fā)展足跡跨越亞洲、歐洲和北美，建立起了20多個研發(fā)和生產(chǎn)基地，涵蓋新藥研究（R）、開發(fā)（D）和生產(chǎn)（M）的各個環(huán)節(jié)。

很多人會問，這么多的全球基地，人員跨越國界、跨越不同時區(qū)與文化，質(zhì)量管理能統(tǒng)一嗎？

這也是德克和他的團隊一直在做的事情。他們的工作任務(wù)之一，就是為公司的化學業(yè)務(wù)平臺建立全球統(tǒng)一的質(zhì)量體系，并擔負起各基地之間“橋梁”的角色。

他們要確保無論在哪個基地，質(zhì)量標準都能保持高度一致，并能在工作中有效實施，既能符合全球監(jiān)管機構(gòu)的法規(guī)和要求，也能滿足全球客戶的需求。

德克坦言，為實現(xiàn)這一目標，在計算機和網(wǎng)絡(luò)技術(shù)不甚發(fā)達的時期，團隊曾經(jīng)非常依賴紙質(zhì)文檔。

而如今，公司早已建立了全球化的信息技術(shù)系統(tǒng)，每一個實驗記錄、檢驗與合規(guī)記錄等都納入了嚴密的內(nèi)部信息管理系統(tǒng)，包含嚴格的權(quán)限管控、完善的審計追蹤功能與信息安全防護，各基地人員可以高效地查閱權(quán)限范圍內(nèi)與自己業(yè)務(wù)相關(guān)的決策與文件。它推動了全球各個基地使用同一套“質(zhì)量術(shù)語”，減少了理解和執(zhí)行上的分歧，也避免了很多中間環(huán)節(jié)與重復(fù)工作，同時也是強化數(shù)字與知識產(chǎn)權(quán)（IP）保護的“護城河”。

德克設(shè)想，未來或許還會有更高效的系統(tǒng)來管理信息、并進行預(yù)測分析，以及統(tǒng)一的系統(tǒng)來實現(xiàn)流程實時監(jiān)控甚至實時發(fā)布，這是行業(yè)的大趨勢。

略作沉思之后，他又談到更深一層的感悟：“技術(shù)升級、打通信息系統(tǒng)固然重要，但背后始終要有人的參與”。

用他的話說，這叫做“讓知識跟著人流動起來”。

首先是自上而下的統(tǒng)一培訓。他的團隊會根據(jù)需要請各業(yè)務(wù)領(lǐng)域?qū)＜抑贫ú⒏孪嚓P(guān)流程，流程一經(jīng)批準，就會在公司內(nèi)部開展標準化培訓，確保所有參與的人員都訓練有素、對齊標準。

其次是同事之間的相互學習交流。新基地投產(chǎn)前，新的QA負責人會前往其他基地“取經(jīng)”；其他基地的QA負責人以及有經(jīng)驗的團隊成員也會出差前往新基地，協(xié)助當?shù)亍皬?fù)制”規(guī)范與經(jīng)驗。以公司正在建設(shè)的美國米德爾頓基地為例，擬任當?shù)豎A負責人的同事曾到中國其他基地“取經(jīng)”數(shù)周，這樣明年年底啟動運營后就能快速開展工作。

“要讓客戶在不同基地體驗到始終如一的優(yōu)質(zhì)服務(wù)”，這種精神也得到了客戶高度一致的認可。

不少客戶會使用藥明康德多個基地的服務(wù)，他們常常會給德克這樣的反饋：“感覺一切都整合得非常好”。

不止于“做對、做好”，而是“做得更好”

在德克看來，這套高標準、嚴要求的質(zhì)量體系，也是公司質(zhì)量文化的體現(xiàn)，它源于一條深深刻在藥明康德基因里的價值觀——“做對的事，把事做好”。

而且在公司的質(zhì)量文化中，不止?jié)M足于“把事做好”，還會鼓勵大家不斷思考“如何做得更好”。

圖片來源：123RF

在質(zhì)量團隊的工作中，如何才能做到更好呢？

德克給出了一個簡潔而又令人深思的答案：要保持積極、開放的態(tài)度。

他表示，大家理想中的狀態(tài)是萬無一失。但現(xiàn)實的情況是，事前規(guī)劃、準備得再好，也難免會有意想不到的問題出現(xiàn)。

面對這些問題，一味地掩蓋或抱怨并不能讓人成長，更重要的是開誠布公地拿出來積極討論，發(fā)現(xiàn)問題、解決問題。

當然，保持開放的態(tài)度并不意味著問題可以改了又犯，這會嚴重影響成本與速度。要吸取教訓、杜絕類似的事情再次發(fā)生。

首先，“開放”體現(xiàn)在對待客戶審計的態(tài)度上。

每年數(shù)百次的客戶審計，德克與他的團隊每一次都以非常積極、開放、透明的態(tài)度去面對，從來不會將其視為“負擔”、或是帶有“如臨大敵”的疏遠回避心態(tài)。

在外人看來，這是“真金不怕火煉”，是對公司質(zhì)量體系信心十足的體現(xiàn)；而在他們眼中，“真金就要經(jīng)得起千錘百煉”，這恰恰是一個讓公司質(zhì)量體系從不同視角接受檢驗的機會。

當客戶提出一些小建議時，團隊總是會認真地對待，或是為其提供合理的解釋與說明，或是與業(yè)務(wù)同事一起思考如何真正改進、做好風險預(yù)警。

每一處提升質(zhì)量的細微改進，也如同恰到好處的煉金之火，日積月累，將質(zhì)量體系錘煉得越發(fā)精細、完善。

這一點也深受客戶贊賞。客戶們在審計完成后常常會表示“藥明康德的質(zhì)量體系非常成熟”，并對質(zhì)量體系的執(zhí)行充滿信心。

其次，“開放”還體現(xiàn)在公司內(nèi)部的溝通上。

有時不同業(yè)務(wù)團隊會發(fā)生意見不一致的情況，比如測試同一個產(chǎn)品時，結(jié)果卻有所不同，雙方就會開始各抒己見。

遇到這樣的情況，德克與他的團隊會鼓勵大家傾聽并尊重彼此的觀點，共同找到更好的解決方案，并把問題寫進培訓案例，讓不同基地的同事一起學習，合作共贏。

在QA團隊內(nèi)部，德克也常常強調(diào)開放與合作的重要性：“不要認為你們是某個基地的QA團隊、他們又是另一個基地的QA團隊。要記住，我們是同一個QA團隊，每個人都要相互支持。”

正如中文“人”字的寫法——兩筆相互支撐，才能形成一個穩(wěn)定的結(jié)構(gòu)。

而三“人”成“眾”的穩(wěn)定，來自每一個人都朝著同一個方向的勇往直前。

這個共同的方向，是藥明康德“讓天下沒有難做的藥，難治的病”的愿景。

如果說藥明康德是護送新藥到達治療疾病彼岸的航船，其質(zhì)量體系就是船上每一根牢固的釘，每一塊堅實的板。

歷經(jīng)26年風浪，它們穿越時間，成了藥明康德堅守不變的厚重積淀，行穩(wěn)方能致遠。

Building Systems That Protect Patients Around the World

Editor’s Note: “Every drug can be made and every disease can be treated”. Since 2000, from a single laboratory to a global network spanning Asia, Europe, and North America; from early chemical synthesis services to an integrated platform that connects Research (R), Development (D), and Manufacturing (M); from its very first customer to thousands of partners across more than 30 countries, WuXi AppTec has never stopped moving forward to realize its enduring vision.

In tribute to the journey, we look back through the eyes of our “dream-makers”: revisiting the stories of partnership that empowered global innovation, and the unique spirit that continues to guide us toward the next chapter.

On weekends, when the emails slow and the lights dim in the office, you might find Dirk Tormans doing something unhurried: walking. Long stretches of trails and quiet city paths give him time to reflect, to unwind, to think several steps ahead. And when he is not walking, he immerses himself in strategy games. He smiles when he explains this hobby, and it makes perfect sense. Strategy games require planning, discipline, anticipation, and the willingness to learn from experience. In many ways, they echo the mindset that guides his work.

Over the past three decades, that mindset has shaped a quality system that supports innovators around the world as they develop new medicines, advance regulatory submissions, and move therapies from discovery to patients. It is a system defined not only by compliance, but by consistency, transparency, trust, and shared purpose.

A System Built to Be Inspection-Ready, Every Day

When a regulatory authority or a client walks into a WuXi AppTec site, the system they encounter is not assembled for a single audit; it is designed for daily execution. This principle has shaped the company’s approach to quality under the leadership of Dirk, Head of QA, who describes his role as less about directing and more about facilitating a system in which quality is part of how people work every day. He often notes thatquality cannot be something performed only when someone is watching; it must be embedded in routine practice, in how records are kept, how deviations are handled, and how teams understand procedures, and the reasons behind them.

Image Source：123RF

This philosophy was evident during a recent unannounced FDA inspection, a common practice to ensure GMP quality, at one of WuXi AppTec’s manufacturing sites. Investigators arrived without prior notification and began their review. The teams did not need to adjust or prepare; they continued operating under their established systems. The inspection concluded with no observations. For Dirk, the significance was not the result itself, but what it confirmed:a system in which readiness is the everyday state, not a special event.

The foundation for this readiness is a structured quality framework that spans the full arc of pharmaceutical manufacturing: from raw-material qualification and supplier oversight, through production execution and equipment calibration, to analytical verification, packaging, storage, and shipment. Dirk emphasizes that this framework is strengthened by people, not just procedures.He frequently points to the dedication of site teams, describing quality as “a total company responsibility,” upheld through collaboration and shared accountability.

In more than two decades of global operations, this framework has been examined in hundreds of regulatory inspections across agencies worldwide. During this period, WuXi AppTec reports no critical regulatory findings, no enforcement actions, and no product recalls. In a landscape where a single recall can disrupt patient access to essential therapies, this sustained history reflects not only technical rigor, but the shared commitment of thousands of people to protect patient safety.

One Global Quality System, Consistency Across Continents

As WuXi AppTec’s platform has expanded across regions and time zones, Dirk has focused on ensuring that quality feels familiar wherever work is done. This effort, years in the making, began with global growth in mind and centered on a practical aim:people at different sites should follow comparable ways of working and understand why those practices matter. This approach led to the One Global Quality System, a unified framework that aligns expectations across locations.

A key step in making this possible was transitioning from paper-based processes to global computerized systems. This shift did more than digitize records; it allowed decisions and quality documentation to be interpreted consistently across the network. It helped sites speak the same “quality language,” reduced ambiguity, and supported oversight without duplication.

Within this framework are global quality procedures: standardized GMP and best-practice requirements co-developed by subject-matter experts across the network. Once approved, these procedures are implemented through standardized training, ensuring that teams understand not only what to do, but how their work will be evaluated across the organization.

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The integration of the Couvet, Switzerland, manufacturing site demonstrates how the One Global Quality System is implemented. Rather than building a new local system, Couvet is connected to the established global framework; adopting the same global quality procedures, computerized systems, and standardized training used across the network. QA leaders from other sites spent time in Couvet to understand routines, explain expectations, and map local processes to the global framework. Subsequent inspections by Swissmedic, the FDA, and Brazil’s ANVISA proceeded without interrupting production, indicating that the site had fully aligned to the global system as intended.

The same approach guides newer sites in Middletown, Delaware, and Singapore. Dirk notes that leaders are being embedded early, and quality systems are established before operations begin. In Dirk’s words,the work is about “building bridges” among sites so that knowledge moves with people and questions are resolved consistently and transparently.Consistency, in his view, is not identical facilities; it is a shared standard, supported by common systems, procedures, and training, that allows work to be understood and improved across the network.

Dirk confirms that clients repeatedly validate the impact of this approach. “Very often I get feedback that they experience a consistent quality of service across the sites,” he says. In practice, that consistency saves time and costs: for example, a qualification audit at an API site often lets them limit audit time at a downstream drug-product site because the procedures, computerized systems, and training are the same.

Quality Culture: the Human Foundation that Creates Client Experience

Yet the strongest systems in the world cannot function without the right culture. For Dirk, culture is where quality truly lives.He believes that WuXi AppTec’s quality culture aligns with its simple, but meaningful principle: “Doing the right thing; Doing it right.”Doing the right thing reflects intent: acting in the interest of patient safety and scientific integrity. Doing it right speaks to discipline: carrying out the work with rigor and clarity, so that decisions stand up to scrutiny.

This mindset shapes daily actions.Quality is not the responsibility of one department; it is the responsibility of everyone.This shared ownership means deviations are not hidden or minimized but openly examined.Mistakes are treated not as failures to be punished, but as opportunities to understand, learn, and prevent recurrence.Teams support each other across functions and sites when challenges arise, reflecting a belief that success and improvement belong to the whole organization.

Clients also experience this culture during their own audits. WuXi AppTec hosts hundreds of client audits each year, and the tone is consistent: transparent, welcoming, collaborative.Instead of treating audits as disruptions, teams treat them as opportunities to strengthen the system, demonstrate confidence in practice, and learn from external perspectives.

Clients frequently describe the experience as reassuring: not because everything is perfect, but because the organization approaches both strengths and challenges with maturity and openness.As Dirk explains, clients consistently share the same takeaway after an audit: The quality system is very mature, and they feel very confident in how it is executed. They may offer recommendations, and these are always welcomed. What clients see in the closeout discussions is a commitment to take every observation seriously, evaluate it carefully, and use it to drive continuous improvement.

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For many emerging biotechnology companies, WuXi AppTec’s quality infrastructure becomes more than a service. It serves as a cornerstone of regulatory credibility, an enabler of INDs and marketing submissions, and ultimately, a safeguard for the patients they hope to reach.

Looking Ahead, Preparing for the Next Era

The future of quality assurance is evolving. Advanced therapeutic modalities will demand deeper integration between analytical development and manufacturing control. Regulatory oversight is shifting toward real-time evaluation, continuous monitoring, and data-driven assessment of quality maturity. Predictive analytics, digital batch records, and eventually real-time release will reshape how manufacturing and quality teams interact.

Dirk is preparing for that future now: strengthening infrastructure, developing cross-site leadership, and ensuring that every new site is not just compliant, but capable of sustaining excellence from Day One.

When asked what WuXi AppTec’s vision — “Every drug can be made and every disease can be treated” — means to him, Dirk answers with quiet clarity:

“It means we work hard every day to make sure patients can receive high quality and new medicines they need.”

And then, when the workday ends, he walks again, steady, thoughtful, and deliberate. Because quality is not a destination. It is a journey. And Dirk is still walking it.

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