Panda Perspectives: Smarika Kafle

Smarika Kafle didn't set out to work in quality assurance. She set out to make a difference, and QA turned out to be exactly where that became possible.

Originally from Nepal, Smarika completed a Bachelor's in Pharmacy before earning a fully-funded Erasmus Mundus scholarship to pursue a joint Master's in Sustainable Drug Discovery across Europe. It was during those years of academic research that a question began to take shape: what happens to all the science after the lab? Of thousands of compounds studied, only a tiny fraction ever reaches patients. She wanted to be part of the system that makes that journey happen and happen safely.

Today, she's a Quality Assurance Officer in the Netherlands, where she places herself at the intersection of compliance, collaboration, and patient impact.

For Smarika, the pull toward the life sciences was always personal. "These patients could be our parents, siblings, partners, or even ourselves," she says. "That makes the impact very meaningful." But it wasn't just the mission that drew her in; it was the pace of the work, the rigour it demanded, and the measurable impact the industry has had over time, including reductions in mortality from major diseases such as cancer, stroke, and heart disease.

What she didn't expect was how collaborative it would be. Her academic experience had been rich and stimulating, but industry collaboration operates on a different level entirely, with cross-functional teams working toward a shared goal with real stakes attached. That suited her well.

She also knew early on that she didn't want to stay purely within research. "I always asked myself: what's the next step? How do discoveries actually reach people?" That question pointed her toward regulated environments, not just manufacturing, but the broader ecosystem of compliance, quality, and operations that underpins everything biotech produces.

Smarika's first industry role was as a Supply Chain Kitting Technician at Galapagos, where she assembled patient-specific kits of critical consumables used in decentralised CAR-T manufacturing. It was precise, high-stakes work and immediately grounding.

"I remember being struck by how structured and compliance-driven everything was," she says. "Every step had to be documented, and even a very small error could have a big impact on patient safety." Coming from academia, it was a different pace. But it was also deeply motivating. She knew the kits she put together were going directly to patients in clinical trials for blood cancers.

What she discovered in that role, beyond the technical skills, was how interconnected everything is. QA, QC, supply chain, and operations: none of these functions works in isolation, and success depends on their ability to communicate clearly and share responsibility.

One of the more surprising aspects of biotech manufacturing? The people who handle the product are also the main source of contamination. "Everything has to be sterile, pristine, and meticulously controlled," she explains. "There are rigorous gowning procedures, strict aseptic techniques, and the operation runs 24/7." It's a far cry from what most people imagine when they think of manufacturing.

Perhaps more importantly, it's also where she discovered what really energised her: the moment things went wrong, and she got to help figure out why.

"Whenever I got involved in a deviation or helped troubleshoot an issue with the quality team, that's when I felt the most fulfilment."

It was a clear signal. Root cause analysis, cross-functional investigation, CAPAs, these weren't just processes to Smarika. They were the parts of her job she found herself thinking about outside of work. So when her first contract ended, she worked with Caitlin at Panda to move toward quality. Within weeks, a Quality Assurance Officer role had been identified, interviews arranged, and the transition completed.

Her current role involves GMP documentation and electronic quality systems, including Veeva. But beyond the technical scope, it's fundamentally about supporting processes, making sure that things are recorded correctly, that the right frameworks are in place, and that teams can move forward with confidence.

The biggest learning curve? Changing how she understood QA's role in the first place.

"QA can sometimes be perceived as a roadblock," she says. "But I've had to see myself differently, not as someone stopping things, but as someone enabling processes to move forward in a safe and compliant way." Balancing quality standards with operational pace is something she describes as an ongoing practice rather than a solved problem. But it's precisely that tension she finds meaningful.

Ask Smarika how she sees QA's contribution to the bigger picture, and she'll talk about prevention before compliance.

"QA contributes by being proactive rather than reactive," she explains. "By making sure principles are followed early on, you're preventing much bigger problems later, such as regulatory delays, failed inspections, and product recalls. Those slow a program down far more than any QA review ever would."

There's also a longer-term logic to it: when structures are well-built, everything becomes more consistent and predictable. People know what to do, how to do it, and what's expected of them. Errors decrease. Processes improve. The system gets stronger over time.

She also sees QA as the connective tissue in an increasingly outsourced industry. "A lot of biotech manufacturing is outsourced, which can make the process feel detached from the company," she says. "QA ensures external partners adhere to the same GMP and quality standards as the originating company." It's the function that makes sure the product a patient receives reflects the intent of the team that designed it, regardless of how many hands have been involved.

Smarika is clear that her own journey wasn't linear by accident; deliberate choices shaped it.

Her first piece of advice: identify an entry point, not a destination. "You don't need to have your entire career figured out from day one," she says. "Your first few years are about understanding how you work, what areas you enjoy, and what gives you a sense of purpose." She deliberately chose a supply chain role because it provided exposure to multiple functions and the end-to-end manufacturing process, which ultimately helped her transition into QA.

She's also a strong advocate for contract work, particularly for those trying to break into life sciences. "It's a great way to get your foot in the door, build experience quickly, and assess your long-term fit to the field" Smaller companies, she adds, can often provide greater responsibility, faster decision-making exposure, and more direct involvement in operations.

On the day-to-day reality of GMP environments, her message to newcomers is straightforward: "GMP isn't there to scare you, it's designed to create a safe system that prevents errors. Mistakes will happen. What matters is that you own them and learn from them." Human error in GMP, she explains, is often treated as a system gap rather than a personal failure and that reframing matters enormously for building confidence.

Finally, she emphasises mindset. "If one path doesn't work, you have the knowledge and abilities to take another. Confidence comes from knowing you can't really lose."

Looking ahead, Smarika is excited about advanced therapies, particularly CAR-T and gene therapy, as well as psychiatric medicine and metabolic health. What connects these areas is the same thing that drew her to the industry in the first place: complex science in service of patients who genuinely need it.

Her longer-term vision is ambitious. She sees biotech moving from retrospective quality review toward a far more integrated approach, with real-time data, predictive analytics, and digital tools embedded across the entire product lifecycle. "I imagine a world where quality is built into every step," she says. "Not tested at the end, but continuously optimised."

The future she describes isn't one where technology replaces people. It's one where people are freed up to do what only people can do: think, collaborate, solve, and decide. QA, in that world, is still the foundation: just a smarter, faster, more proactive one.

For Smarika, that's not an abstract aspiration. It's the direction she's already building toward one documented deviation at a time.

Smarika began her career in life sciences through Panda. If you're a recent graduate or international professional looking to break into biotech or pharmaceutical operations, get in touch with us here, and a member of our team will reach out to start the conversation.