As CEO of Proqlea Ltd., Josipa Ljubičić has built her leadership on scientific excellence, integrity, and a deep commitment to patients. With more than two decades of experience in the pharmaceutical industry, her career spans clinical trials, regulatory affairs, and quality assurance across international markets. A certified GCP, GMP, GLP, and GVP auditor, she has conducted over 700 GxP audits and 80 regulatory inspections in more than 120 countries, helping organizations strengthen compliance and ensure the safety and quality of medicines and vaccines.
A defining shift in her journey came during the COVID-19 crisis, when she recognized the gap between scientific progress and public understanding of clinical research. Driven to promote ethical, transparent, and patient-centered trials, she founded Proqlea with a clear purpose: to combine quality, education, and clinical innovation while expanding access to life-saving therapies, especially for patients facing rare and incurable diseases.
Let’s delve into the interview details below!
What was the original vision behind Proqlea, and how has that vision evolved as the company has grown under your leadership?
The original vision behind Proqlea was to create a highly specialized consultancy focused on GxP auditing and quality management systems, helping companies navigate EMA and FDA requirements in a practical and transparent way. As we grew, this vision evolved into a broader mission: becoming a quality-driven CRO that supports clinical trials end-to-end, with a particular focus on rare diseases. Over time, we also integrated a strong social and educational component, including initiatives dedicated to rare and incurable diseases and collaboration with associations and institutions active in this space. Today, Proqlea’s vision is to be a bridge between science, regulation, and humanity; raising standards while improving access to innovative therapies.
How would you describe your leadership philosophy when guiding teams and making strategic decisions in a highly regulated and innovation-driven pharmaceutical industry?
At the core of my leadership philosophy is trust, both within the team and in our relationships with clients. Trust is difficult to build and easy to lose, and over the years I have seen many capable professionals fail this test. I believe that once trust is established, productivity naturally becomes the standard. People work with clarity, ownership, and a genuine sense of responsibility toward patients, colleagues, and partners. Those who sustain both trust and high performance over time become the most loyal and impactful members of the team.
I do not believe in micromanagement, but I have learned that true leadership requires investing time in individuals. In today’s environment, staying focused on a meaningful long-term goal is challenging. There are many distractions and often very little real support, especially for those who think differently or choose a less conventional path. That is why I make a conscious effort to understand each person’s strengths, concerns, and ambitions, and to remind them of the larger purpose behind our work.
With clients, my approach is based on partnership rather than a transactional relationship. I strive to be transparent, honest, and solution-oriented, even when conversations are difficult or timelines demanding. In a highly regulated and innovation-driven industry, this balance of trust, performance, and open communication enables strategic decisions that are both compliant and forward-looking, while building lasting relationships that create value for everyone involved.
What strategies does Proqlea use to foster innovation and scientific excellence while maintaining agility and compliance?
We start from a strong quality and compliance backbone and then build innovation on top of it. Proqlea invests in a robust QMS, clear SOPs, and continuous training so that regulatory expectations are not a constraint but a platform for innovation. On that basis, we encourage cross-functional, project-based work, use digital tools, and collaborate with laboratories, technology partners, and academia to integrate advanced analytics, AI, and precision medicine concepts into our services. Regular internal audits, lessons-learned sessions, and scientific reviews help us refine processes while staying agile and responsive to client and regulatory needs.
What has been one of the most significant challenges you have faced as CEO, and how did it influence your approach to leadership and problem-solving?
One of my biggest challenges as CEO has been maintaining internal stability in a fast-growing, predominantly female company with many young professionals at different stages of life and career. As a women-led organization, we experienced several team members going on maternity leave or pursuing new opportunities at the same time. For a short period, I found myself with only three fully effective employees in the entire company. Instead of panicking, I paused and realized this was an opportunity for a new beginning, one I could shape with clarity and intention. Over time, I learned that those who need to leave will do so, and those who stay become your true support. The experience revealed who genuinely shares the company’s values and resilience.
At the same time, relationships with clients and vendors bring ongoing challenges. I address issues through open communication and a solution-focused mindset, while accepting that some situations are beyond my control. I recall difficult mistakes in accounting and financial processes that I did not cause and could not fully prevent, yet they carried significant financial and operational consequences. These experiences strengthened me and reinforced an important lesson: no matter how much you know, growth requires humility, continuous learning, and the ability to adapt without compromising your values.
How do you ensure that Proqlea’s work remains patient-centric while also delivering long-term value to stakeholders?
At Proqlea, we always remember that behind every protocol or audit are patients and families, often facing rare, complex, or under-treated conditions. This perspective guides our approach to study design, site selection, data integrity, and safety monitoring. At the same time, we provide value to sponsors and stakeholders by minimizing compliance risks, strengthening the reliability of evidence, and supporting efficient, high-quality clinical development. By aligning patient benefit with operational excellence, we create a sustainable model where ethical responsibility and business performance support each other rather than conflict.
As a female leader in the pharmaceutical sector, how do you view the importance of representation, mentorship, and inclusive leadership?
Representation is crucial, particularly in life sciences, where diverse perspectives can directly influence research priorities and patient outcomes. As a female CEO, I see visibility and accessibility as part of my responsibility, showing that women can lead in highly technical, regulated, and strategically complex environments. Mentorship plays a big role: I actively encourage younger professionals, especially women, to take ownership of their careers, to specialize in demanding areas like clinical trials and QA, and to trust their expertise. Inclusive leadership, for me, means valuing different backgrounds, experiences and structuring teams so that everyone’s voice can genuinely influence decisions.
What advice would you give to aspiring leaders in the life sciences industry, and what are you most excited about in Proqlea’s future journey?
My advice is to build a solid scientific and regulatory foundation, stay curious, and never forget why this industry exists: to improve and save lives. Technical skills are essential, but so are resilience, humility, and the courage to challenge practices that no longer serve patients or science. Surround yourself with people who complement your strengths and give them room to grow.
Looking ahead, I am especially excited about Proqlea’s role at the intersection of rare diseases, women’s health, and digital innovation, including our ambition to strengthen access to clinical trials and experimental therapies in our region. I believe we can help position Croatia and the wider region as a serious hub for high-quality, ethically grounded research that benefits both local and global patient communities.
Visit us at our first Health & Business Growth Summit in the region, taking place from 19–21 May 2026, and discover why we truly live the values we stand for and the work we do every day.
