In Conversation With Gilda D’Incerti, Founder and CEO of PQE Group

March 8, 2023

PQE Group, founded by Gilda D’Incerti in 1998, offers technology solutions and compliance consulting services to the life sciences industry. It has been ISO 9001-certified and has over 1500 subject matter experts working across over 30 offices worldwide. The company specializes in various areas such as Data Integrity Assurance, Digital Governance and Cybersecurity, Medical Devices, Qualification and Engineering, Laboratory Excellence, Quality Compliance, Regulatory Affairs, and Third-Party Audits.

The team has a proven track record of managing large multi-site projects as well as small, medium, and start-up clients in the pharmaceutical, biotech, and medical device industries. By partnering with PQE Group, you can be assured that your company will maintain compliance with FDA and other regulatory agencies, and that your product can be safely developed and manufactured.

In celebration of International Women’s Day, BioBuzz caught up with D’Incerti to learn more about the story behind the company, how PQE Group has continued to grow tremendously across the world, and its plans for the future.

Could you tell us more about your career path leading up to your role as Founder/CEO at PQE Group?

Well, I suppose it all started when I graduated with a degree in Economic Statistics from the University of Bocconi in Milan, Italy. Following graduation, I worked extensively in the field of Information Technology and specifically, IT Compliance on both a national and international level for companies such as Siemens Data (Milan) and Edicon (Montreal). Before I established PQE Group in 1998, I was the IT Manager for the Menarini Group’s Spanish affiliate in Barcelona, after which I became Executive Consultant in Validation and Operations Manager for F&J Systems Italy and ultimately for M.I.S.

What was your motivation for starting PQE Group? 

I have been heavily involved with IT systems since the early 80s. When the subject of SW Quality in Life Science began to circulate (at the beginning of the 90s, before GAMP first edition) I had a strong feeling that the validation of IT systems and related data security would become a strong business driver due to the upcoming digitalization processes that the manufacturing companies in life sciences were putting in place. For this very reason, I ended my direct involvement in the industry and moved to consultancy. After some successful years as a consultant, I was actually fired for not sharing with my employer my vision of selling, at the same time, SW products and validation services, and this triggered the idea of starting my own business.

My vision since that day 25 years ago was to create an organization that would appreciate and respect its employees, help them learn, grow and be successful, and at the same time, support pharmaceutical clients to achieve quality and compliance for their products. I wanted to create a business where people think outside of the box, especially in the male-dominated field of IT Consultancy, where most of the competition utilizes staffing agencies. Our approach is based on having core employees with a high level of expertise – homegrown managers and young talents that can develop their skills within our community, providing turnkey solutions and effective management to our clients.

We started PQE as a small start-up in Tuscany, Italy, with five senior consultants and a common interest:  delivering the highest expertise within the life sciences space and ensuring patients’ safety. And with respect to our employees and our culture, our vision remains the same to this day — to create a diverse work environment with no discrimination and where transparency and respect come first. This is our strength.

Talk to us about how you successfully grew PQE Group into an international company with over 2,000 employees – what do you think were the most important factors for your success?

It’s funny – PQE stands for Pharma Quality Europe, because when I founded the company in Italy, our market was pretty much just Italy. Of course, we grew throughout Europe before expanding into other continents and today, 25 years later, we have 22 legal entities, 34 offices around the world, and approximately 2000 employees who speak more than 25 languages. 

I think there are many factors that have helped us achieve such dramatic growth, which has occurred especially in the last five or so years – we recruit and hire experienced professionals of all ages and backgrounds, and ensure that our employees bring strong knowledge, expertise, and passion to their jobs. Our subject matter experts are just that – experts – who are also extremely supportive and helpful to our clients, developing true partnerships instead of just solving problems.

We have expanded our service portfolio to include essentially every area of compliance consulting, and our extensive experience and effective project management, along with exceptional cost-effectiveness, allows us to provide support to global companies in the pharma and medical device industries, as well as start-ups, small and medium size companies. We work with a “glocal” focus – we hire and act locally, so our people speak the language, know the culture, and don’t have to travel from around the world to client sites – while thinking globally, with global knowledge, input, and collaboration available to our clients and employees regardless of their location. This strongly helps with our success because it truly helps us provide the best solutions to our clients.  

On the flip side, what’s been the biggest challenge you’ve had to face in growing the company? How did you overcome it, and how did it shape your leadership style today?

I think that, like so many other companies, the COVID pandemic created huge challenges for us. Italy was hit hard, and many of us got sick, lost loved ones, and of course, we were in lock-down mode for some time. I am so proud of my staff, who persevered throughout and worked from home, identified remote ways of working that were very useful and successful (and are still used to this day), and were creative with ways to support our company and our clients despite the obstacles created by the pandemic. And while I have always given all of my staff substantial leeway to exercise their own ideas and offer new ways of working, perhaps COVID helped reinforce that concept is the best way to lead – give people the ability to grow and thrive, and respect and appreciate their new ideas, unique skill sets, and ways of accomplishing objectives.

We’ve heard a lot of great things about PQE’s culture – how do you maintain a strong, positive company culture, especially across multiple international offices?

My vision is, as it always has been, to create a work environment with no discrimination. I recognize and value how diversity and talent development can be a great added value to business models at all levels. I evaluate the company’s performance not only by revenue but by the number of people we have hired because my mission as an entrepreneur is to employ as many people as possible regardless of gender, race, religion, and age.  

I’ve been fortunate that the people who make up PQE Group are dedicated, passionate, and extremely kind. Our culture has continued to evolve into one that is focused on being diverse and inclusive, socially responsible, helpful and collaborative. Most of the PQE Group employees participate in CSR activities and team building initiatives. We have internal communications people in all of our regions who regularly disseminate news and information via various channels, and who work with the PQE Group staff in their regions on team and community efforts. We are open and communicative, and ensure that information is shared and participation is encouraged. We work hard, but we also have fun.  

We just saw the team is opening a new location in Raleigh, NC. How will this expansion contribute to PQE’s mission?

Yes – we recently opened an office in Raleigh, NC, as well as in San Diego, CA and Buffalo, NY. We are very excited about these new locations, in particular in Raleigh, as it is home to the Research Triangle, where we already work with several clients and anticipate rapid growth as we bring more professionals into the area. We look forward to working closely with BioBuzz as it also grows its presence in the Research Triangle life science community.

The opening of these, and other, new offices around the world reinforce our mission of becoming the largest life sciences consulting firm in the world. We already boast the largest number of subsidiaries and with our recent dramatic growth, I think we are on our way to achieving that mission.

What advice do you have for budding women entrepreneurs and business leaders?

My advice to budding women entrepreneurs and business leaders is to stay strong, maintain robust networks throughout your industry, be open to suggestions and help from others, and never stop learning and growing – yourself as well as your company! I think that women entrepreneurs should not imitate men, but should foster a new leadership style more based on soft values and a revolutionary approach.  Hire like-minded people whose values reflect yours, maintain a healthy company culture, and ensure your employees feel empowered and included. Stay on top of industry trends and requirements to ensure clients always receive the most current and relevant support. Fully respect and appreciate your clients, your colleagues, and your staff. And always, be kind to yourself and allow yourself time to enjoy the softer areas of life as well as the tougher requirements of growing and leading a company.