Corporate Director Quality and Regulatory
Kristin Gordon is the Director of Quality and Compliance, the Americas, for Alere Inc. She was appointed to her current position in March 2011. Previously, she served as Director of Quality and Regulatory Affairs. Ms. Gordon joined Alere in 2004. Since then, she has held a number of management positions in product development and project management, as well as quality and regulatory, in Alere’s Infectious Disease Diagnostics business. In the infectious disease business, she served as Director of Product Development and Director of Project Management.
Kristin will be one of the distinguished speakers at the 6th Annual Diagnostic Quality Assurance Conference.
Why is the 6th Annual Diagnostic Quality Assurance Conference important for quality assurance executives?
I think the biggest value that this conference brings to the attendees is perspective. It is so easy to get tunnel vision within our companies and our roles. Sharing ideas, strategies and approaches with peers who understand the generalized obstacles of the industry, so talk the same language, but have a different perspective because they aren’t involved in the day to day activities at your business. You only need to walk away with one new idea or approach (and a lot of new contacts) and the conference is a huge success.
What initiatives are on the horizon at your organization for the quality assurance department in 2015-2016?
Implementation of a global PLM is one of our biggest initiatives. With over 150 sites worldwide, it is a tool that will help us with our business integration and sharing of best practices.
Are there any sessions or topics you’re looking forward to discussing at this year’s conference?
I am really excited about the session on proposed regulation of laboratory developed tests. The topic is certainly at the forefront for the LDT community, but I’m really interested in how the changes in regulation will directly and indirectly impact commercial diagnostic regulation.
How has your organization improved risk management within the quality assurance department?
I have two sites in my geography that have really robust risk management processes, but their approaches are really quite different. Having them share their processes with other sites, and having those sites realize that risk management isn’t a one size fits all type of process, has led to a lot more creativity and development of processes that really fit the individual organizations.
How do you believe that advanced technologies impact quality management systems?
Hands down, the biggest impact that advanced technologies have on the QMS is that it gives you information at your fingertips.
What are your/your team’s goals for the coming year?
The goal that is most critical to my team is growing the QA team members. Part of the growth is training, but a big piece of the investment will also be exposure and experience.
What are three key areas to examine when selecting quality management systems?
I don’t see quality management systems as something that you select; rather they are something that you create to support the business. What you select are the tools that you will use to build and maintain the QMS. In the selection of these tools, the three things that I would consider first are:
- Fit for the business now
- Fit for the business in the future (5 to 10 years)
- Ability to validate
And finally, what keeps you up at night?
Interpretation. Interpretation of the regulations, interpretation of customer needs, interpretation of patient needs, etc. Interpretation is one of those skills that you really can’t teach, as it is really based on a type of logic, and it is the skill most needed in our industry.