The Role of Institutional Knowledge in Quality Assurance
Jonathan Spaans began his career in the biotech industry in the 1990s. Over the past 20+ years, he transitioned to GMP manufacturing, drug testing, and the clinical side of testing. Having the opportunity to work with different companies, Spaans received a well-rounded education and experience in the drug procurement and manufacturing processes. “I’m able to look at things from multiple viewpoints, such as the manufacturing perspective, the client perspective, those who are creating the therapy, and the company who is actually doing testing.”
With his unique background, he has been able to create comprehensive quality management systems because he knows exactly what’s important. One of the biggest changes he has seen in the industry is how information is organized and communicated. “Instead of just working with Word and Excel documents, quality management has moved towards automated, cloud-based platforms. This has allowed us to increase our level of compliance in a number of different ways, such as document management, version control, and training.”
As Director, Quality Assurance at Champions Oncology, he spearheaded the implementation of ComplianceQuest’s EQMS and feels that this has created a renewed sense of ownership and responsibility for those involved. “ComplianceQuest helps me focus document ownership on a particular person, even though many people play a part in its creation.”
Spaans has a deep interest in knowledge management, how it’s ascertained and managed, and how to take advantage of that knowledge. He has been involved in how the whole system fits together—from operations, to compliance, to regulations. “The quality industry is more attuned to people who are interested in how institutional knowledge is managed, and this is in sharp contrast to someone who is in operations for research or the development of particular compounds.”
To continually improve the quality culture at Champions, he focuses on making sure that institutional knowledge is well established. “Ownership levels should be well-defined, but you can’t build culture unless you have a solid communication system. We have a very open, informal, and interactive culture, but we take seriously what clients are engaging us for.”
Spaans and his team help shape the quality culture at Champions by being engaged, helping broker decisions, getting people together, and discussing gaps and opportunities.
“I’m someone who likes to oversee certain systems that are going through development and making sure that people are successful. I enjoy making sure whatever we do is adding value, seeing the results of adding that value, and seeing my personal worth in a company. My agenda is to make sure that people find use of quality to help them be more proactive and productive.”
