We are thrilled to announce the newest addition to the Compliance Architects® family, Mr. Diluks De Silva, who joins us as an Executive Consultant. With over 20 years of extensive experience in the life sciences industry, Diluks brings a wealth of expertise in Cell and Gene Therapy (CGT), Radiopharmaceutical Therapy, Theranostics, Biopharmaceuticals, Commercial Operations, and Quality.
Diluks mentioned how he felt about joining the Compliance Architects® team. He said:
“Embarking on this new chapter with Compliance Architects has been an immensely gratifying experience thus far. The driving force behind my decision to join the Compliance Architects team lies in their unwavering commitment to core operating principles and the substantial value they consistently bring to the organizations they support. What sets them apart is not just their methodology but the tangible impact they make in ensuring compliance and operational excellence.
Interestingly, my connection with Compliance Architects predates my role on the team. As a client, I had the firsthand opportunity to witness the effectiveness of their strategies and the positive transformation they facilitated within the organizations they partnered with. This personal experience fueled my enthusiasm to become a part of a team that truly stands by its principles and actively contributes to the success of its clients.”
Professional and Educational Background
Diluks served as the Head of North American Country Quality at Novartis, Advanced Accelerator Applications (AAA), where he oversaw quality operations for AAA site operations, Radio Pharmacy operations, and supply chain operations in North America. His role as a member of the country’s commercial executive leadership team and the global quality leadership team at AAA showcased his strategic leadership and innovative approach.
One of Diluks’ notable achievements includes leading the first commercial CART-T (KYMRIAHTM) Quality Manufacturing organization, expanding its reach across the US, EU, and APAC regions. His pioneering efforts significantly influenced and redefined the regulatory landscape supporting Cell and Gene Therapy commercialization.
Before his role at AAA, Diluks played a crucial role in the BioProduction Operations Singapore team at Novartis. He led the construction and commissioning of a new 700 MUSD cell culture production site, demonstrating his proficiency in greenfield design, manufacturing, quality control, and product launches.
Diluks holds a B.S. in Biology from California State University, Sacramento, California, reflecting his strong foundation in the biological sciences.
Diluks shared his thoughts on his favorite aspect of his current role. He said:
“Immersing myself in a team of individuals driven by a shared passion for crafting purposeful solutions within the intricacies of a highly regulated environment has been a truly invigorating experience. Each day is marked by the collective commitment to finding solutions that meet regulatory standards and are tailored to our dynamic landscape’s specific needs.
Thus far, the journey has been marked by the joy of creating business solutions beyond mere compliance. It’s about understanding the unique challenges of our environment and devising strategies that align with regulations and drive efficiency and innovation. Working alongside like-minded professionals, the collaborative energy fosters an environment where every solution is meticulously crafted to be fit for purpose.”
Leadership and Achievements
Diluks has demonstrated exceptional leadership in handling FDA inspections for pharmaceuticals, biologics, and advanced therapeutic products throughout his career. His sponsorship of Six Sigma initiatives in QC and QA at Novartis optimized quality and compliance, yielding significant business and patient benefits.
Personal Background
We also spent some time asking Diluks questions about his personal life. Here’s what he had to say.
What Activities Do You Enjoy For Fun?
“I enjoy traveling and thrill of exploring new destinations, crafting delicious meals for my friends, capturing moments through the lens of my camera, snowboarding and driving fast cars.”
Can You Share a memorable experience from one of the best practices you’ve ever visited?
“My wanderlust has taken me to various corners of the globe, and amidst the diverse landscapes and cultures, one profound commonality stands out—the shared threads of pure happiness and gratitude. Having traversed Southeast Asia and explored the vastness of the African continent, my lens has captured not just picturesque landscapes but the genuine smiles and heartfelt expressions of gratitude that define the essence of a simple life.
In Southeast Asia and across the African continent, I’ve been immersed in the unique joy that emanates from living in harmony with simplicity. The moments I’ve encountered reflect a deep sense of grounding, an overwhelming thankfulness for life’s basic blessings, and the beauty of sharing whatever one has, no matter how modest.”
What’s Your go-to Favorite Food?
“All of it.”
Advice on Quality Compliance From our newest Member
Finally, we asked Diluks if he had any advice on maintaining quality compliance. Here is what he had to say.
“In the realm of maintaining quality and compliance in the pharmaceutical industry, the advice I offer is rooted in a fundamental privilege that we hold – the ability to “Make,” “Test,” and “Release” products that have a profound impact on people’s lives. It’s not just a task; it’s a responsibility and a privilege to contribute to the well-being of those in need.
To safeguard and perpetuate this privilege, it becomes imperative for researchers, developers, and manufacturers of these lifesaving products to uphold the highest standards of quality and compliance across all operational facets. It’s about more than just meeting regulatory requirements; it’s about ensuring that each step in the process is a testament to our commitment to excellence.
Your insights will contribute to a comprehensive blog post about your career, allowing colleagues and readers to get to know you better. The products we create today are the lifelines for someone tomorrow – perhaps even ourselves. It’s a poignant realization that one day, whether through circumstance or fate, you or I may be the ones relying on the efficacy of these medicines.
The driving force behind my dedication to the pharmaceutical industry for over 25 years is the profound understanding that, one day, it could be you or me relying on the therapeutic efficacy of a medicine. It’s this awareness that fuels my relentless pursuit of maintaining the highest standards, ensuring that each product we contribute to is not just compliant, but exceptional in its potential to heal and improve lives.”
Join Us in Welcoming Diluks De Silva
Please join us in extending a warm welcome to Diluks De Silva as he takes on the role of Executive Consultant at Compliance Architects®. We are confident that Diluks’s strategic vision, innovative thinking, and extensive industry knowledge will contribute significantly to our ongoing success.
We look forward to the valuable contributions Diluks will make in driving innovation, fostering collaboration, and further enhancing our capabilities in the dynamic field of life sciences. We wish Diluks a successful and fulfilling journey with Compliance Architects®! Learn more about Diluks on our company staff page here.
Welcome aboard, Diluks De Silva!