Elena’s preferences (lightning round)
- Quality vs quantity? “Quality of course”
- Chicken wings or Chicken Kyiv? “Chicken wings”
- San Diego or Chicago? “San Diego”
- EpicentRx or anywhere else? “EpicentRx. By far. No other company compares.”
Elena Prokopenko, the subject of this write-up, is a quality person. That is certainly meant as a compliment, she is warm, friendly, funny, and intelligent, after all, but also as a statement of fact. Elena is the EpicentRx Head of Quality.
So, what is quality anyway?
Sound of head scratching.
This is a really hard word to get a handle on. It implies excellence, superiority and capacity; it is a standard and an inherent feature, and, depending on the context, it is subjective and objective. Err…right?
The fact is that the more one tries to define quality and articulate its exact meaning, the more one gets tripped up. The dictionary is no help at all since no less than 19 definitions for quality are to be found there, 15 as a noun and 4 as an adjective–and don’t get us started on the thesaurus, which provided hundreds of synonyms both as a noun and an adjective. That is the very definition of quantity over quality.
The next step was to ask, or rather ASQ, the American Society for Quality (ASQTM) for a definition. This is a real organization, by the way, (who knew?), which boasts approximately 80,000 members on its website, and which presumably spent years on a single definition, thumbing their nose at the dictionary and the thesaurus, only to come up with quality is “a subjective term for which each person or sector has its own definition”. Wait, what? Quality is…whatever we say it is?
Go figure that the person to explain it best and to provide some much-needed context is Elena Prokopenko, a non-native English speaker from Ukraine and a quality person in every sense of the word. According to Elena, quality is defined broadly in objective terms as “fitness for purpose, which means that the product, whatever it is, performs consistently as intended.” Consistency is a key word for her, and in the pharmaceutical industry, quality means that a drug or device meets prespecified regulatory specifications or standards imposed by the FDA or other regulatory agencies depending on the “stage of development”.
So how do Quality Control (QC) and Quality Assurance (QA) come into play, two terms that are frequently bandied about and combined as QC/QA? Well, it’s complicated, as Elena makes clear, but QA and QC are all about the establishment of consistency (there’s that word again).
Elena is the EF Hutton of EpicentRx, which is a reference to a television ad for a brokerage firm from the 1980s that featured the slogan, “When EF Hutton talks people listen!” Likewise, when Elena talks, everyone consistently and attentively listens so as not to miss any QC/QA pearls.
A former elementary school teacher with a masters in biochemistry, Elena comes to EpicentRx by way of Genstar Therapeutics. Born in Odessa, Ukraine on the Black Sea, Elena emigrated to the United States in 1992, fittingly just in time for her husband’s and the nation’s birthday on July 4th with 2 children in tow. Now a doting grandmother, who enjoys biking, hiking, and skiing, Elena directs the whole QA/QC program at EpicentRx with tremendous energy and passion.
So, why not hire a bigger team to surround and support her given how incredibly busy she is? That will happen soon enough. But for right now, it’s quality over quantity.