An Interview with Gilero’s Vice President of Quality & Business Systems

Kristin Benokraitis joined Gilero in 2007. As one of the team members who has been with Gilero the longest, she has had the unique opportunity to watch Gilero grow, and help fuel that growth, over her tenure with the company. Kristin herself has grown too, serving in various quality, project management, and operations roles, working her way up to become the Vice President of Quality and Business Systems.

Your title recently changed from the Director of Quality and Operations to Vice President of Quality & Business Systems. What does this shift mean?

“Previously, I was involved in leading projects and day-to-day ownership of the Quality Management System. Now, I act more as an advisor and take on strategic projects for the company as a whole.”

What do you do as the VP of Quality & Business Systems?

“My role gives me the opportunity to look more holistically across the business and identify ways to streamline our approach, implement tools to promote efficiency, and ensure consistency across all of our sites as we continue to grow.  One of the foundational elements of our business is our Quality Management System, which is critical for compliance to industry regulations and ensuring that our products are safe and perform effectively. Other supporting functions, such as regulatory, legal and IT also fall under my ownership responsibilities.”

How do we help our customers navigate quality and regulatory challenges?

“Being aware of current regulatory landscape and trending industry practices is important to Gilero and our clients, as no one likes surprises. Our clients ask for our support when there are gray areas, requiring interpretation of the regulations. We provide insight, consultation and recommendations based on our historical experience, knowledge and understanding of the client’s goals. One example is when we work with our clients who are developing a combination product, but have a Quality System structured to the pharmaceutical regulations. Our team can provide guidance on how to develop the device constituent in accordance with the regulations, while utilizing a streamlined approach.”

Why is Gilero’s regulatory service offering so valuable to our customers in the medical device and pharmaceutical industries?

“The most valuable part of offering regulatory services in-house is that we interact daily with the engineers who are designing the product, authoring documentation, building prototypes, and testing samples in our lab. Knowledge transfer and internal regulatory consultation can occur in real-time as the design, intended use or labeling is imagined or iterated, leading to efficiencies gained throughout the development process. Our team interacts with regulatory agencies directly, through activities such as pre-submission meetings and authoring regulatory submissions. This knowledge and experience provides a feedback loop directly to our engineering team to ensure the products we develop and manufacture are consistent with current industry practices and regulatory agency expectations.”

As Gilero grows as a business the Quality Management System must expand as well. Tell us about your role in facilitating that growth.

“Our Quality Management System (QMS) needs to flexible in a way that works for our diverse client base, while remaining compliant to regulations. Having an overarching QMS with site-specific procedures allows us to simplify the development and manufacturing transfer process and use consistent language between functions and sites. When new capabilities or locations are added, our team works together to develop procedures to ensure consistency and ongoing compliance across sites. We have mechanisms to monitor the health of our Quality Management System which help inform what is working and what is not.”

You’ve been with Gilero for almost 15 years, working your way up from Quality Engineer to where you are now. What makes you stay?

“I love challenges and thrive in a fast-paced work environment. Simply stated, there is never a boring day at Gilero. As an engineer, building and solving problems is core to who I am. Throughout my career at Gilero, I have had the opportunity to do both. It is very fulfilling to lead programs, work with clients and see novel products reach the market. I’ve also had the opportunity to help our team grow Gilero from a single design center to the company that we are today. It’s really something to be proud of and I’m grateful for the opportunities I have had at Gilero.”

Did you always know you wanted to be a part of the leadership team?

“It’s interesting to look back and think about how my career has evolved. As a young child, I had dreams of being an astronaut. After college, I started out in the plastics industry as a process engineer. My career then shifted to the medical device industry, finding a role in quality. It turns out that my natural strengths align well with the world of quality and regulatory. My experience over the years has required me to walk in the shoes of the team I currently lead, giving me insight and appreciation for what we are able to accomplish every single day. What excites me now is having the opportunity to help shape the ‘future Gilero’, as we take our business to the next level. To me, the title or seat at the leadership table is the ‘cherry on top’, but it isn’t what drives me as a person.”

What’s your favorite thing about working for Gilero?

“I really enjoy the journey associated with developing people, especially raw talent. The people at Gilero differentiate us from our competition. Coaching team members is a commitment of time and effort, but I consider it an investment into the future. I look to the team members I have mentored over the years, and I’m proud of their accomplishments and the roles they have taken on within the organization.”

Posted in: Gilero News, Quality & Regulatory