Besins Healthcare
Building Smarter, Safer and More Sustainable QA Systems
Imane Rouggani
Imane Rouggani is a distinguished pharmaceutical executive with more than 15 years of experience in quality assurance and global operations. She holds a Doctor of Pharmacy degree from the Faculty of Pharmacy at ChâtenayMalabry in Paris, a master’s degree in quality assurance and an Executive MBA from La Sorbonne Business School. Rouggani has held senior leadership roles at prominent pharmaceutical companies, including Bristol Myers Squibb, Novartis and Alcon. As Head of Global Quality and Deputy Qualified Person at UPSA, she led the development and implementation of a global quality management system supporting operations in more than 60 markets.
Currently, she serves as Director of Global Quality Operations at Besins Healthcare, where she is responsible for ensuring manufacturing and distribution quality across more than 100 markets. In this role, she upholds the highest standards of safety, regulatory compliance and operational excellence.
In an interview with Life Sciences Review Magazine, Rouggani emphasises the challenges in pharmaceutical quality assurance and the importance of a patient-centric approach and risk management in shaping the industry's future.
Ensuring Compliance with Evolving Regulatory Requirements
Quality assurance (QA) in the pharmaceutical industry is vital in building trust and ensuring safety. As companies operate across global markets, their QA systems must align with a wide range of regional regulatory requirements. Agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) frequently revise their guidelines. Recent updates to the FDA’s Good Manufacturing Practices (GMP), for example, have introduced stricter documentation and auditing standards, prompting companies to reassess their quality frameworks.
Navigating these shifts calls for more than routine compliance. It demands sharp regulatory intelligence and a proactive mindset. By closely tracking regulatory changes, companies can stay ahead of the curve and ensure their QA systems remain both compliant and adaptable.
However, meeting regulatory requirements is just one part of the equation.
At its core, QA is about protecting patients. Every decision made—from the selection of raw materials to final product distribution—should reflect a commitment to safety. Even minor quality issues can have serious consequences, which is why a patient-first approach must guide every aspect of QA.
Implementing strong risk management practices is key. When decisions are evaluated based on their potential impact on patients, QA teams can focus their resources where they are most needed. Identifying critical control points and addressing them early not only prevents failures but strengthens operational efficiency.
With the right balance of regulatory insight, risk-based thinking and patient-centric values, pharmaceutical companies can elevate their QA systems to meet today’s challenges and tomorrow’s expectations.
Smarter Systems, Safer Outcomes
One of the biggest challenges in healthcare today is validating emerging technologies, especially AI and ML. These tools are increasingly used in QA to predict issues and optimise testing. But they’re only as effective as the data behind them.
AI models rely on high-quality, standardised and accurate data. Inconsistent input leads to unreliable output—resulting in poor predictions, quality lapses and compliance risks. That’s why data integrity is critical.
Balancing quality, compliance and sustainability in a globally connected, tightly regulated industry is no longer a future challenge—it’s today’s reality. For QA teams, the question is not if these issues can be addressed, but how quickly and effectively they can rise to meet them.
Equally important is ongoing validation. AI systems must be continuously tested to ensure they function correctly and don’t introduce bias or errors into decisions.
Integrating AI and digital tools into QA also hinges on people. A digitally skilled workforce is essential. QA teams must receive ongoing training to keep pace with new tech and global regulations.
With rapid advances in AI, automation and regulatory expectations, staying up to date is no longer optional—it’s essential.
Looking ahead, pharma will be transformed by breakthroughs like personalised medicine, AI-driven drug discovery and biologics. Tailored treatments will improve outcomes and reduce side effects.
AI will accelerate drug development through data analysis and smarter clinical trials. Biologics, including gene and cell therapies, will expand options for treating complex conditions.
The future of pharma lies at the intersection of innovation, quality and people.
The Triple Challenge: Supplier Assurance, PostMarket Vigilance and Sustainable QA
Supplier quality assurance is a growing challenge in the pharmaceutical industry. Companies rely on third-party suppliers for raw materials and APIs, making it vital to ensure consistency and quality across a fragmented global supply chain. But this is easier said than done.
Variations in raw materials can impact product quality, especially when suppliers operate under different regulatory standards. For instance, a drug made in Europe or the U.S. may use ingredients sourced from countries like China or India, where expectations may not align with FDA or EMA guidelines. This places a heavy burden on QA teams to conduct thorough, resource-intensive audits across borders.
Post-market surveillance is just as important. Regulatory bodies now expect ongoing monitoring of drug performance in the real world. QA teams must track adverse events, gather real-world data and ensure its accuracy across decentralised clinical trials and digital platforms—adding another layer of complexity.
Sustainability is also gaining urgency. As environmental concerns rise, pharmaceutical firms are being pushed to align quality standards with greener practices. This includes reducing waste, cutting energy use and responsibly sourcing materials—challenging tasks in a field that relies on precision and controlled logistics.
Today’s pharmaceutical QA teams must navigate a delicate balance: maintaining quality and compliance while adapting to real-time data demands and sustainable practices. These are no longer future concerns—they are pressing, immediate challenges.
Words to Lead By
Adaptability is no longer optional. As the pharmaceutical industry rapidly evolves, advancements in AI and personalised medicine are transforming how we work. Keeping pace with these changes means embracing technology, staying flexible and committing to lifelong learning. These qualities are now essential for anyone aiming to stay ahead.
Innovation thrives on collaboration. Breakthroughs often come when people from different backgrounds come together, bringing fresh ideas and diverse expertise. Interdisciplinary teamwork plays a key role in solving complex challenges and driving progress.
At the heart of it all is the patient. No matter how advanced the technology or how bold the innovation is, the end goal must always be to improve lives. A patient-centric mindset ensures every step forward truly serves those who rely on us.
Equally important is holding firm to values like integrity and sustainability. Ethical decision-making and environmentally responsible practices are not just good business, they are critical for building a healthcare system that lasts.
