In our second Leading the Way interview, Snezana Stojilkovic, Frontier Zdravlje’s Quality Director, shares insights from her 30-year journey—from researcher to leading quality operations. She discusses the challenges of maintaining top-tier standards in a CDMO, the power of cross-team collaboration, and how our commitment to excellence drives success.

1. You’ve been with Frontier Zdravlje for nearly 30 years and recently stepped into the role of Quality Director. What has been the most rewarding part of your journey with Frontier Zdravlje, and how has it shaped your approach to leadership?

It’s hard to believe it’s been almost 30 years! Reflecting on this journey, over this time, I’ve been part of Frontier Zdravlje’s transformation, from starting as a researcher, to roles in process validation and QA management, and now as Quality Director. Each step shaped both the company’s quality systems and my own growth through continuous learning and adapting to challenges.

I developed leadership skills by working on key projects like validating a new production facility and fostering a culture of accountability and continuous improvement as QA manager. Today, as Quality Director, my focus is on new products, clients, regulatory inspections, and building strong relationships to support Frontier Zdravlje’s growth.

Continuous learning has been essential, and I’m proud to have completed two specializations— Industrial Pharmacy and QP — while balancing family life as a wife and mother. Above all, expertise is vital in this role, as every decision in Quality must be based on sound and independent judgment to assure the quality of our products and protect the company’s sustainability.

2. What do you see as the most critical challenges in maintaining top-tier quality standards in a CDMO business, and how does Frontier Zdravlje overcome them?

Constant changes and stricter regulatory standards pose a challenge for CDMO companies.

To ensure compliance, Frontier Zdravlje carefully monitors and implements all local and international guidelines, such as GMP standards, along with regular internal and external audits to maintain high-quality standards at all stages of production.

Maintaining consistency in production and controlling all process parameters across all production batches is critical to preserving quality. Frontier Zdravlje uses automated systems to monitor and optimize manufacturing processes, reducing the likelihood of errors and ensuring consistency.

Ensuring the quality of raw materials and thoroughly testing them is of paramount importance. Frontier Zdravlje works with qualified suppliers and conducts rigorous testing of raw materials before they are used in production.

The expertise of Frontier Zdravlje employees is crucial to quality, as inadequate training can lead to errors. Continuous training and development ensure that our team stays up-to-date with new technologies and procedures.

Through these approaches, Frontier Zdravlje successfully overcomes challenges and consistently delivers high-quality products to its partners and the market.

3. How do you collaborate with other departments to maintain a strong quality culture across the entire organization?

Our quality team collaborates across departments and integrating quality into every aspect of our operations, create a robust quality culture through the entire organization, ensuring the consistent delivery of safe, effective, and high-quality pharmaceutical products.

We prioritize collaboration between quality assurance, quality control, regulatory affairs, manufacturing, M&ST and supply chain teams and by fostering this approach, we ensure that quality is integrated into every phase of the product lifecycle.

We established a Quality Board that includes representatives from each department. These committees meet regularly to discuss quality performance metrics, review non-conformances, and identify opportunities for continuous improvement. In this way we ensure alignment with the organization’s quality objectives and full compliance with EU c-GMP and regulatory requirements.

We collaborate with other departments to define and track key quality performance indicators (KPIs) that reflect the overall effectiveness of our Quality System and maintain open communication channels between departments to promptly address quality-related issues, ensuring fast resolution and alignment with organizational goals.

We engage all departments in internal audits to evaluate compliance with quality standards and identify areas for improvement. Findings from audits are discussed with relevant departments to ensure corrective and preventive actions (CAPA) are implemented in a timely and effective manner, reinforcing a culture of continuous quality improvement.

4. Frontier Zdravlje has successfully passed various client and health authority GMP inspections. What were the key strategies or actions behind this success?

In 2024, Frontier Zdravlje successfully completed 10 client audits, a mock inspection, and a six-day EU GMP inspection by the Malta Medicines Inspectorate. The EU GMP certification, in particular, was pivotal in securing market approvals and reinforcing our commitment to patient safety and product quality.

• Fostered a culture of compliance, emphasizing the importance of adhering to GMP guidelines, encouraging employees to report any potential non-compliance issues
• Designated a dedicated GMP inspection team responsible for overseeing the preparation and coordination of GMP inspections, careful planning, attention to detail, and a proactive mindset to achieve successful outcomes.
• Conducted mock inspections to identify any gaps or areas for improvement and allow employees to become familiar with the inspection process.
• Conducted internal audits to identify any potential non-compliance issues and provide an opportunity to address them before an official GMP inspection.
• Trained employees effectively and regularly reviewed and updated quality control procedures to align with current industry standards.
• Maintained a clean and organized facility
• Continuously improved our quality system through audits/inspections as opportunities for improvement, learning from any observations or recommendations made by the inspectors and taking proactive measures to address them.

Transparent and professional communication during inspections also played a critical role. Our team demonstrated integrity, answered questions with candour, and provided requested documentation promptly, fostering a collaborative atmosphere with inspectors. This achievement highlights the dedication and expertise of our team, reaffirming Frontier Zdravlje’s position as a leading pharmaceutical producer.

5. What are your priorities for the quality team moving forward, especially after the recent GMP success?

Building on our EU GMP success, the quality team’s priorities for 2025 focus on sustaining daily inspection readiness, effectively implementing and monitoring CAPAs, and preparing for new transfers, products, audits, and inspections.

To stay ahead, we will actively track industry trends, participate in conferences and training, and maintain strong engagement with regulatory authorities. Cross-departmental collaboration will be key, with regular meetings to align efforts, address challenges, and ensure a unified approach to GMP compliance.

These steps will position us to meet future challenges while maintaining the highest standards.