Meet Ece Smrdelj

Quality Assurance and Regulatory Affairs Manager Diagnostics - Australia

So what is it you do?

My official role at AsureQuality Australia is Quality Assurance and Regulatory Affairs Manager and I am a part of the senior management team. I ensure that products manufactured, supplied and distributed by AsureQuality Australia are registered, safe and meet their intended purpose. In short, I’m the conscience of AQ Australia!

Tell us a little about your work background

I have spent 30 years working within the human and veterinary therapeutics and diagnostics industry in Australia and internationally in Europe, North America and Asia Pacific.

My first job was with the Commonwealth Serum Laboratories (now known as CSL) as a Technical Assistant Grade II, shortly after I was promoted to Area Manager responsible for the manufacture of antigens and bacterial vaccines. This first job instilled a love of manufacturing, my ‘can do attitude’ and a thirst for learning as much as I could.

Most of my professional life was spent leading and shaping teams in manufacturing, warehousing, distribution, regulatory affairs, quality assurance, quality control, training and education, and facility design, commissioning and licensing. I worked for organisations such as GSK, DBL (now Pfizer), CSL Behring, Sypharma, and many others as I entered into the domain of consulting. Furthermore, my need for new challenges and value-add results then led me into the world of medical devices, and other companies such as Johnson and Johnson, Smith and Nephew, and Rofin Australia.

What do you like most about working at AQ?

I haven’t decided what I like the most about working at AQ, as I haven’t been exposed to the wider business yet, however I can say AQ Australia has stolen my heart. AQ Australia is the quintessential team; unity empowers everything it does. I am honoured to be a part of a group of people, which regardless of the magnitude of challenges (challenges come often, thick and hard here), always strives for success. They are already global experts in what they do.