Quality in drug development is often discussed in terms of systems, audits, and regulatory expectations. But for Dipesh Patel, the foundations are far more human. As he puts it, giving people the space and safety to do their best work is what ultimately drives meaningful innovation and resilient quality systems. It’s an approach shaped by a career spanning CDMOs, biotech start-ups, and large-scale pharmaceutical manufacturing.
Now leading Quality at Ardena, Patel is focused on keeping systems simple as the company expands into new modalities, strengthens its bioanalytical capabilities, and adapts to fast-evolving regulatory and technological landscapes. His strategy emphasizes data-driven decision-making, strong internal and external partnerships, and a practical, scientifically informed understanding of risk. In this conversation, he reflects on the lessons that shaped his leadership philosophy, the ambitions guiding his work today, and the trends that he believes will define the next era of CDMO quality.
What key lessons have you taken from the different organizations you have worked in?
Regardless of the type of organization, we always deliver through the actions of great people. Things I have learned throughout my career include the importance of a compelling common vision for the quality organization. It’s the value of a clear shared purpose, we all want to look beyond the day to the horizon.
Furthermore, giving people enough space and a safe environment to do their job and innovate is fulfilling for them, and they will then, inevitably, develop solutions to the most pressing needs.
What achievements do you consider the most defining in your professional journey?
I’m very grateful to have worked with phenomenally capable people throughout my career. People who set the bar high and then provided opportunities to learn and grow. It is through such leaders that I saw what excellence looks like, what to aim for. This has coincided well with my natural tendency, a ‘restlessness’, to always want to make things better – a continuous improvement mindset.
These for me have been key to building trust and good working relationships with customers and regulators alike.
What are the primary functions of a Chief Quality Officer?
Leadership first! That means defining what quality means in practice, not just theory, and therefore building an organization that has a mature capability and approach to quality risk management. This then serves customers through a culture of common-sense compliance and phase-appropriate policies that accelerates the development of safe and efficacious medicines.
What are your primary ambitions in your role?
To keep things simple and effective as we scale up, and to support growth in new modalities such as nanomedicine, and fast-growing services like bioanalysis for global clinical trials.
It is too easy, with time, for a quality management system to become unwieldy. Bigger is not always better, and unnecessary complexity can create its own compliance challenges. We need to remain focused on efficiency, evaluate how best to use our resources, distil down to the things that truly matter, and prevent the introduction of complexity that does not add value.
What are the most significant challenges in maintaining compliance and operational excellence in such a dynamic regulatory environment?
To build and maintain solid partnerships with our customers and suppliers, we need highly developed communication channels, internally and externally; this will help us in being as nimble as required. Underpinning this we need to maintain robust, yet simple processes so that we can adapt to needs as quickly and compliantly as possible.
How do you think scientific understanding can shape a data-driven approach to quality assurance?
Scientific understanding and quality principles go hand in hand. You have to use data and experience to determine what processes should look like, how to monitor and manage those processes and how to evaluate risk.
It is important to always lean on the scientific expertise of colleagues to help build reliable operational processes. It’s also vital to have a quality and regulatory department with a very solid background in the sciences – that helps shape a careful and systematic approach.
What emerging trends in the CDMO sector do you think will most influence quality strategy in the coming years?
The adoption and application of AI tools must be at the top of this discussion. It will transform what we do from development right through to operations. It is an exciting prospect to move faster and with greater patient safety and efficacy outcomes, while also freeing capacity for people to engage in more value-adding activities and innovation.
Alongside AI, the shift toward precision medicine is becoming increasingly influential. As therapies grow more targeted and patient populations more defined, Quality organizations need to support faster, data-rich development cycles with agile processes and scientifically sound decisions. This includes ensuring that risk assessments and control strategies can adapt to smaller, focused clinical programs, and to accelerated approval pathways that demand clarity and speed.
A further trend is the increasing complexity and expectations in bioanalysis, driven by novel modalities and the expanding scope of global clinical trials. This calls for even closer alignment between Quality and bioanalytical teams so that methods, study designs, and associated processes remain fully suited to the scientific and regulatory demands of these advanced programs.
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