Trine Ruby,
Director of Quality Assurance
My name is Trine Ruby and I am Director of Quality Assurance (QA) at NMD Pharma. My day-to-day role is in Quality Assurance (QA) and I am part of the Operations team. I work with colleagues across the company, focused on developing our Quality Management System (QMS). As NMD is expanding into more regulated areas of drug development there are several regulatory requirements including the generic good practice (GXP) regulations our work must adhere to, to ensure participants in clinical trials and consumers of medicinal products are protected. Our drug development work will form the basis of regulatory submissions of novel treatments for neuromuscular disorders and must therefore fulfill these regulatory requirements. In addition, the QMS will ensure more standardized and effective business processes.
Besides working with the QMS, I am responsible for ensuring that relevant vendors are audited, and I am involved in collaborating with our vendors and internal vendor managers to ensure that the right level of quality is supplied. In addition, I am always available for any compliance questions from colleagues.
I completed an MSc. in Pharmaceutical Sciences plus a Ph.D. in neuropharmacology, where I investigated the mnemonic deficits in an animal model of schizophrenia. The Ph.D. was co-funded by the University of Copenhagen and H. Lundbeck A/S and included a stay in the UK working at the University of Bradford. After finalizing my Ph.D., I moved to Singapore and joined Takeda as a research scientist. When I moved back to Denmark I joined Novo Nordisk in the Clinical Supplies department, where I worked according to Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP), which is where my interest in compliance started. This led me to a position as a Qualified Person (QP) at Fertin Pharma and a strong GMP focus.
It was a combination of several factors that drew me to NMD. The combination of responsibility for the quality direction of the company, and the fact that I get to develop my skills in Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) while working for a company that strives to improve the quality of life for people with large unmet medical needs. I am proud to say that I am working for NMD and I am proud of our vision.
I like working here because there is a feeling that we are all in this together and we all strive to do our best. In addition, the management makes an effort to ensure that knowledge is shared throughout the company, whether it is information about the latest research, status on the non-clinical or clinical development, or status of investments. The culture at NMD is very positive and enthusiastic. As a new member of the NMD team it is my experience that everyone is happy to ask and answer questions and talk openly about their area of work.