Those who find quality uninspiring have not yet met Helen Kargaryani, Global Head of Quality at NDA. By thinking outside the box and having an exceptionally creative personality, Helen makes quality-related problem-solving crystal clear and even fascinating. Quality in the pharmaceutical industry can be challenging and repetitive. Still,it is an essential part of drug development as it ensures that the end product meets the quality requirements and standards defined for the product or the service.

Helen Kargaryani first discovered the area of quality during her master thesis when she joined Pharmacia in their research and development department. She soon realised that, with her training as a pharmacist, matched with her love of organisation and a keen eye for detail, a career in quality would be a perfect match. In the beginning, Helen was working on quality issues in the manufacturing process.

Dealing with quality assurance in production was indisputably the best way to learn, Helen Kargaryani explains. Whenever a deviation occurred in the manufacturing process, I discussed it directly with the people working on the floor for immediate action.

Helen soon realised that to solve the quality challenges in manufacturing as they appeared, she needed to be able to  analyse the problem to find the root cause quickly. Working in the pharmaceutical industry, a field of constant innovation, issues are rarely the same, and therefore, the solutions must be innovative.

I would not say that I am a traditional quality assessor, Helen states. Existing regulations and standard operating procedures must be followed; this is essential. However, to put a functioning quality management system in place, I need to be able to explain the value and importance to the people who will implement and live by it.

Helen thrives on continuously challenging herself to find new ways of problem-solving and is often inspired by the artistic side of her personality. She is a very visual person and believes that captivating visuals support the process of thinking and understanding.  This helps her to look at challenges from a new and unique perspective.

One size does not fit all, Helen says. I cannot fit every process into the same template. And when I do find a solution, it doesn’t really impact until it is understood and recognised by the recipients. Regardless of whether I talk to engineers, scientists, or consultants, I need to speak their language, use their own terms, and meet them on common ground.

Helen takes pride in preparing organisations for inspections. As a former auditor, she knows what is expected and how to balance the audit requirements with the resources that companies have available. Doing a quality management system (QMS) assessment must result in an organisation that is audit-ready. However, creating an overwhelming number of standard operational procedures (SOPs) is not a sustainable way to work there must be a balance between what is needed and what is good to have. Helen intends always to provide the right level of quality required: not more, not less.

To be able to deliver an optimal quality strategy, Helen believes in taking a holistic approach. She believes that Quality bridges the gap between the organisation and the regulators, as a business partner, providing the overall perspective to support organisations in reaching their business goals.

To build something out of nothing is a tough challenge but very rewarding”, Helen says. “When I create a QMS from scratch, I need to consider not only what the company needs right now but also what needs to be in place to allow the organisation to grow and while trying to predict what their needs will be in the future. I like the thought of leaving a legacy”.

There are a vast number of things that can go wrong during drug development. The solution to a future problem may develop from the interface between science, art, and good ,old-fashioned common sense.

Change is constant, Helen says. I want to continue to be inspired and to keep providing new solutions.