Michelle Bonn Joins PQE Group as Executive Consultant – USA Business Strategy

Michelle Bonn recently joined PQE Group as an Executive Consultant for USA Business Strategy to contribute to PQE Group’s US growth and presence.  She has a long history in the industry, with decades of entrepreneurial experience in both pharmaceutical and medical device development.  We talked with Michelle to learn more about her and her exciting history.  

Michelle, you are relatively new to PQE US, bringing with you a tremendous amount of industry history and experience – most of which is executive and entrepreneurial.  Can you share some of your background with us?

Absolutely. I’ve spent over two decades in the life science space, mostly building and leading companies focused on regulatory compliance, FDA strategy, and global commercialization. I started my first company in international trade, helping global manufacturers enter the U.S. market. Many of those early challenges were FDA-related, which led me to launch Guideline Medical, a consultancy supporting both U.S. and international medical device firms with regulatory strategy.

Over time, I expanded into pharmaceutical engineering by acquiring Compliance Team, a firm I led through a full turnaround; rebranding, streamlining operations, and tripling profit margins. I ultimately sold the company in late 2024 after building a strong pipeline and delivering high-value projects for global clients like GSK and Eli Lilly.

After the sale, I was ready for my next chapter. I had known about PQE for some time. Ironically, our offices in Buffalo were down the hall from each other.  I was impressed by their international reach and collaborative culture. After meeting with the leadership team, it was clear this was a great fit.

Can you tell me what is so interesting about PQE to you?

Initially, when I first met with Mitch Wagner, a PQE US recruiter here in Buffalo, we realized my background in the execution of market expansion and strategic initiatives in the US could really help foster PQE brand name growth in the USA. The process was already successful in Europe and other parts of the world.  Mitch suggested I meet Gilda D’Incerti, PQE’s CEO and Founder. I was impressed with how cohesive the PQE people are; that they continuously look for opportunities to expand, they listen to new ideas, and they maintain a collaborative environment. These are values I have always encouraged in my own companies. I find it rare to see this type of collaboration in a work environment; it excited me and gave me confidence that I could genuinely fit in and continue to grow my career with this organization. PQE was established and is headquartered in Italy. I have worked with both US and European cultures, so I'm happy to bridge our teams together in any way I can for real growth. I’m really very happy to be here.

How does your experience with your own companies shift to your new role within PQE? 

At my previous companies, I worked with organizations of all sizes, from early-stage startups to global pharma leaders, helping them navigate the regulatory landscape and move toward commercialization. That experience directly translates to PQE’s client base.

Now, I’m focused on supporting PQE’s U.S. growth strategy by leveraging my experience in market expansion, capital raising, and operational execution. I’m working closely with the executive and business development teams to build on PQE’s impressive global track record and deepen its presence here in the U.S.

What are you most excited in the role and what is the impact you're hoping to have? What is a major takeaway?
The opportunity to help companies move from regulatory confusion to commercial success. Many firms, especially small and mid-sized, know they need compliance support but sometimes don’t know where to start. PQE is in a unique position to be their partner through that exploration.

I’m excited to expand PQE’s visibility in the U.S. market, expand on existing strategic partnerships, and ultimately support our clients in launching safe and effective products. We have the talent and capabilities—now it’s about supporting existing Italian and US talent to deepen our message and execute sales with precision across the U.S.

What about yourself? Who is Michelle outside of the work environment?

I’m a hiker, a problem-solver, and a builder at heart. I love taking ideas that don’t seem connected and turning them into something meaningful and functional. This is how I’ve approached both life and business.

I also enjoy being the bridge between highly technical teams and business leaders. My background spans quality systems, data analytics, and clinical research, but I’m equally passionate about leadership, storytelling, and strategic thinking. This role at PQE really brings all of that together. This opportunity, I believe, is perfect for both me and PQE. I look forward to the adventure ahead.

About PQE Group

PQE Group is a leading provider of quality solutions for the pharmaceutical and medical device industries, with a global presence and expertise in various regulatory and compliance areas. The company is a women-owned Contract Quality Organization and Complete Quality Solution provider for GCP, GLP, GMP & GDP areas in the Life Sciences. PQE Group has a long history of supporting companies of all sizes and exceeding compliance standards. The company is dedicated to creating value for its customers by putting its multidisciplinary teams and knowledge at their service, allowing clients to achieve and maintain compliance with the latest regulations, and contributing to creating a safer medical device and pharmaceutical environment. With over 30,000 successful projects completed, and 1400+ medical device and pharmaceutical clients served worldwide, PQE Group delivers turnkey quality solutions while focusing on exceptional cost-effectiveness and the highest quality of care. PQE Group specializes in areas including Regulatory Affairs and Strategy, Quality Compliance, Third Party Audits, Data Integrity Assurance, Digital Governance, Qualification and Engineering, and Laboratory Excellence. PQE's global imprint allows for a "Glocal" approach, which focuses on utilizing local support to achieve global success.

Important to note:  PQE Group will hold its fourth US roadshow on June 10, 2025, in Philadelphia, PA.  A panel discussion featuring industry experts will focus on generative AI, and will be followed by an authentic Italian aperitivo.  We hope to see you there (https://webinar.pqegroup.com/innovation-in-life-science-roadshow-usa-pqe-group).