Clinical trials might sound like a dry, technical world — piles of data, strict rules, and endless paperwork. But if you dig a little deeper, you find it’s really about people: the patients who need safe, effective medicines, and the teams who work tirelessly behind the scenes to make that happen. At the heart of it all is quality assurance, or QA for short. This isn’t just about ticking boxes or following rules to the letter. QA is the glue that holds clinical trials together, making sure everything is honest, safe, and trustworthy. And with how fast the clinical research world is changing — new tech, remote trials, and all sorts of complexity — the role of QA professionals has never been more important.
Now, meet Josipa Ljubičić. She’s the CEO of Proqlea Ltd, but she’s much more than a title. Josipa Ljubičić journey to the top is a story of passion — for science, for IT, and for making quality assurance not only more efficient but more human. She’s one of those people who sees the bigger picture: QA isn’t just the “final checkpoint” before a trial is done; it’s a vital part of designing trials that work better, safer, and smarter from the very start. At Proqlea, Josipa and her team are building tools that help QA pros step up and become true partners in clinical trials, not just watchdogs. They’re turning quality from a burden into an advantage.
Josipa Ljubičić story feels refreshing because it’s about blending curiosity, technology, and real-world impact. She didn’t set out to become a CEO from day one. Instead, her path meandered from lab work to regulatory affairs, through CROs, and finally landed in QA — where she realized this was where she could make the biggest difference. “I was always a ‘weird’ kid who didn’t fit into a box,” she says, “but I could mix with everybody.” That same spirit shines through her leadership today: flexible, innovative, and always people-first.
Let’s explore her journey, the challenges QA teams face, and how technology and mindset shifts are shaping the future of clinical research quality!
A Journey Rooted in Passion and Purpose
Josipa Ljubičić path wasn’t a straight line. It’s more like a winding road shaped by curiosity, flexibility, and a genuine passion for quality in clinical research. “I’m Josipa Ljubičić , currently the CEO of Proqlea Ltd. And officially certified auditor for multiple GxPs,” she shares simply, but there’s a lot behind those words. Her career has brought together experience in science, regulatory affairs, IT, and clinical operations, a combination that’s as rare as it is valuable.
She reflects on her early days working in the R&D lab at GSK, then moving into Regulatory Affairs at Pliva, the Croatian brand under Teva Pharmaceuticals. These roles weren’t just jobs; they gave her a deep understanding of the pharmaceutical industry from many perspectives. “My journey started quite humbly. I’ve always been passionate about science, quality, clinical trials, and business itself,” she explains. It’s clear that for Josipa Ljubičić , this has always been about more than just a career. It’s a true passion.
What really sets her apart is her love for IT and her drive to bring technological innovation together with pharmaceutical rigor. This rare mix fuels her vision: connecting IT experts with pharma to create “amazing things that will help industry but in the same time that will spread a view of IT experts.” That vision became Proqlea Ltd, a company founded on a simple but powerful idea to make quality and compliance not only more efficient but also more human and impactful.
Navigating the Complexities of Quality Assurance
The journey into quality assurance within clinical trials was not a straightforward one for Josipa Ljubičić . Her career highlights a gradual shift towards QA as she recognized the importance of not just performing tasks but ensuring that everything is done “right—and that it holds up under scrutiny.” She found herself drawn to QA because it represented structure, purpose, and a chance to influence outcomes meaningfully.
“I liked the idea of not just doing the work, but making sure it’s done right—and that it holds up under scrutiny,” she shares. This mindset led her to focus on clinical trials, an area where quality directly impacts patient safety and data integrity. Over time, her expertise expanded beyond clinical QA to encompass pharmacovigilance (PV), manufacturing, distribution, and laboratory quality systems, making her a well-rounded professional within the industry.
She found clinical trials to be the perfect place to put her passion for continuous improvement into action, especially because the environment is so complex. “I realized that this world needs simplified and easy solutions since it is always hard to respect the rules,” she reflects. For Josipa Ljubičić, making QA simpler and more intuitive is key to navigating the tangled web of regulations and delivering real impact.
Reframing the Role of QA Professionals
One of Josipa Ljubičić main motivations is to elevate the role of QA professionals beyond the traditional, limited view. She observed that QA teams were often seen as gatekeepers at the end of the process rather than as active collaborators throughout the clinical trial. This narrow perspective restricts their ability to positively influence how trials are designed and executed.
She noticed that with the increasing complexity of clinical trials, which involve decentralized models, new technologies, and shifting regulations, it is crucial for QA to be involved from the very beginning.
Josipa Ljubičić strongly believes that QA professionals have much more to offer beyond just audits and checklists. They play a pivotal role in building systems that are compliant and efficient. In her words, QA teams are the ones who can make your wishes come true within the boundaries of regulations and rules, while also providing essential support if any inspections occur. This view underscores the strategic importance of QA as both a protector of compliance and a driver of innovation.
The Indispensable Role of QA in Clinical Trials’ Future
As clinical trials continue to evolve at an unprecedented pace, the role of QA professionals becomes increasingly vital. Josipa Ljubičić describes this role as “absolutely essential, more than ever before.” The industry is witnessing an influx of new technologies, remote and decentralized trial models, and pressure to accelerate timelines without compromising quality.
With these changes, QA professionals ensure the “foundation stays solid.” They translate complex regulatory frameworks into practical processes, safeguard data integrity, and protect patient safety as a fundamental value rather than mere formality. She highlights how QA teams contribute to a culture of continuous improvement, a necessity in today’s fast-moving environment.
“So, I don’t see QA as just a support function. They’re strategic partners in shaping how trials are designed, run, and improved for the future,” she states. This view aligns with the cutting-edge work Proqlea is doing alongside IT experts, developing AI and machine learning models capable of delivering “99% correct diagnostic.” This synergy between QA, operations, and IT represents the future model for quality assurance in clinical trials.
Confronting Challenges in the QA Landscape
Despite its importance, the QA field faces significant hurdles. Josipa Ljubičić identifies one of the biggest challenges as overcoming “non-QA mindsets.” The rapid evolution of clinical trials, driven by digital transformation and decentralized approaches, demands that QA professionals remain proactive and forward-thinking, a task that isn’t always supported culturally or operationally.
Another persistent issue is visibility. QA often suffers from being perceived as reactive—focused on compliance after the fact rather than proactive involvement. This perception limits their influence early in the trial process where their input could yield substantial benefits.
Additionally, QA professionals must continually balance rigorous compliance with the need for agility and efficiency. “Balancing quality with agility isn’t easy, but it’s something QA teams are being asked to do more and more,” she acknowledges. This tension requires innovative thinking and a willingness to embrace new technologies and methodologies to maintain high standards without slowing down progress.
The Pandemic’s Impact
The COVID-19 pandemic served as a catalyst for transformation within QA and clinical trials overall. The sudden shift to remote work and virtual processes forced the industry to rethink traditional models of oversight and compliance.
Josipa Ljubičić recalls how the pandemic “pushed the industry to adapt fast.” On-site audits were replaced by remote audits, documentation went digital, and collaboration became virtual. This shift highlighted the importance of being tech-oriented and adopting risk-based approaches to quality assurance.
“It challenged us to become more flexible, more tech-oriented, and more focused on risk-based approaches,” she notes. Many of these changes are expected to persist, fundamentally altering how QA functions. Importantly, the crisis reaffirmed QA’s critical role in safeguarding trial integrity and patient safety, even under unprecedented conditions.
A New Era for Quality Assurance
Technology is reshaping quality assurance in clinical trials in profound ways. The movement away from manual, paper-heavy processes toward digital, data-driven systems is enhancing oversight, decision-making, and efficiency.
Josipa Ljubičić highlights the rise of electronic quality management systems (eQMS), remote auditing platforms, and advanced data analytics as key enablers for modern QA professionals. At the heart of Proqlea’s mission is the drive to simplify and streamline quality processes, reducing administrative burdens while improving compliance and visibility.
“We’re leveraging tools that streamline document control, automate workflows, and help teams stay compliant without getting buried in admin,” she explains. One of Proqlea’s standout innovations is the use of real-time dashboards and data visualizations, providing QA teams with early warnings and actionable insights.
The ultimate goal is to “free up QA professionals to focus on strategy and continuous improvement, rather than chasing paperwork.” she envisions their technology being adopted far beyond the pharmaceutical industry, revolutionizing quality management universally.
AI and Automation
Artificial intelligence and automation are often seen as disruptive forces, but Josipa Ljubičić views them as powerful tools that enhance the capabilities of auditors and QA teams rather than replace them. These technologies excel at handling repetitive, time-consuming tasks such as document reviews and data trend analysis, freeing professionals to focus on higher-value activities like strategic risk assessment.
“For auditors, AI can support things like intelligent sampling or detecting patterns across trials that might not be obvious through manual review,” she notes. This “extra set of eyes that never gets tired” complements human judgment, which remains irreplaceable.
She stresses, “Good judgment, critical thinking, and ethical decision-making still lie with people. AI is a tool not a replacement.” The future lies in leveraging AI and automation to empower QA teams to identify risks earlier and contribute more strategically to clinical research quality.
Leading a Culture of Innovation and Learning
Leadership at Proqlea is centered on fostering a culture where curiosity, continuous learning, and open dialogue thrive. Josipa Ljubičić believes that staying ahead in QA means never becoming complacent and always questioning existing processes.
“At Proqlea, we invest in ongoing training, attend industry events, and stay closely connected to regulatory updates,” she explains. Beyond formal education, the team is encouraged to share ideas, learn from challenges, and embrace new tools that increase transparency and efficiency.
Her leadership style blends respect for regulatory fundamentals with a readiness to innovate. “Everyone has something to contribute,” she says, reinforcing the idea that quality assurance is a collective endeavor requiring diverse perspectives and ongoing development.
Proqlea’s Breakthrough Platform
Proqlea’s most notable innovation lies in creating an integrated digital platform that centralizes quality oversight activities—document control, training management, CAPA tracking, and audit readiness—within a single intuitive interface. This solution aims to reduce complexity and increase user-friendliness.
The platform’s real-time dashboards and alert systems provide QA teams with a proactive tool to identify issues before they escalate. “Instead of reacting after the fact, teams can now take preventive action based on trends and data,” she explains.
This approach transforms quality management from a reactive necessity into a proactive strategy, enabling clients to streamline processes and enhance compliance. For Josipa Ljubičić and her team, seeing their technology directly improve client operations is a source of great pride.
Anticipating Future Trends in QA for Clinical Trials
Looking forward, Josipa Ljubičić anticipates several significant trends shaping QA in clinical research over the next five years. The continued digitalization of QA processes, including remote audits and cloud-based data systems, will require professionals to be increasingly tech-savvy and adaptable.
Risk-based, data-driven quality management will become standard practice. Rather than exhaustive checklist compliance, QA teams will focus on analyzing trends and early warning signals to guide decision-making.
Collaboration across sponsors, CROs, vendors, and regulators will gain importance, with QA playing a central role in aligning quality expectations across diverse stakeholders. Finally, AI and automation will further evolve to support predictive analytics and smarter quality oversight.
Despite these technological advances, Josipa emphasizes that “the human element, judgment, ethics and critical thinking, will remain at the heart of quality.” The future will be defined by balancing innovation with foundational principles.
Preparing QA Professionals for the Road Ahead
To thrive amid these changes, QA professionals must embrace adaptability, digital literacy, and strategic thinking. Josipa advises cultivating a mindset that goes beyond compliance to add value early in clinical trial processes.
“Building digital skills is a big one,” she stresses, encouraging familiarity with eQMS platforms, data dashboards, and automation tools. Additionally, “soft skills” such as communication, collaboration, and problem-solving are increasingly vital as trials become more global and complex.
By staying curious and open to change, QA professionals position themselves as indispensable contributors to clinical research innovation and quality.
Words of Wisdom for Aspiring QA Leaders
For those entering the field, Josipa’s advice is grounded in purpose and proactive engagement. She urges newcomers to understand deeply the “why” behind QA work—not just to comply, but to protect patients and ensure trustworthiness of research.
“Be proactive. Don’t wait to be told what to check. Ask questions, look for gaps, and think ahead,” she advises. Embracing technology, maintaining curiosity, and seeking connections through mentorship and industry networks will accelerate growth and impact.
She encourages aspiring professionals to “dream big” and contribute solutions that advance clinical trial quality beyond regulatory obligations.
A Leadership Perspective
At the core of Josipa Ljubičić leadership philosophy is a harmonious balance between innovation and compliance. She rejects the notion that these forces are opposed. Instead, she sees them as complementary, with true innovation offering smarter, more efficient ways to maintain compliance.
“I always encourage the team to question processes, not just follow them,” she shares. This questioning mindset drives continuous improvement while staying firmly rooted in regulatory knowledge, risk awareness, and accountability.
“Innovation is important, but trust is earned through consistency and integrity,” she reflects. Her approach combines encouragement of new ideas with a commitment to quality fundamentals, ensuring that progress never comes at the cost of compliance.
