Bob Castellucci Joins PQE Group US as Principal Consultant and Networking Executive

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.

Bob Castellucci recently joined PQE Group as Principal Consultant and Networking Executive to contribute to PQE Group’s US growth and presence.  He has a long history in the industry, with decades of experience in both pharmaceutical and medical device research and development, quality, and remediation.  We talked with Bob to learn more about him and his interesting history. 

Important to note:  PQE Group will hold its third US roadshow on March 11, 2025, in Boston, Massachusetts, where Bob will be a panelist on the important topic of Innovation & AI in Healthcare: how to streamline product lifecycles.  The panel will be followed by aperitivo offering Italian wines and foods. Be sure to join us (registration link). 

You are relatively new with PQE Group, and you bring with you a huge amount of history and experience in the industry.  Can you share your background with us? 

I attended Villanova University back in the 1970’s, where I earned both Bachelors and Master’s Degrees in biology. My dad passed away very unexpectedly, just before my senior year in high school, so I started college at a difficult time in my life. My experience of being away at school at that time was very difficult; however, that adversity really helped the adult Bob emerge. During my undergraduate years, I wanted to be a college professor. Then, in graduate school, I realized that this was not the right dream for me. 

When I began pursuing a career in industry, the ball seemed to bounce in a good way -- and that seemed to happen repeatedly. When I finished graduate school, I got my first industry job with Merck, not at the Merck headquarters in West Point, Pennsylvania, but in rural Virginia. At first, I wondered if I had made the right choice.  It was not the headquarters location, there were not many resources available – but in the end, it taught me how to be resourceful, how to figure out how to get things done without a lot.  And that made me realize that my passion and talent was in being a construction guy! 

Following Merck, I was given opportunities at a number of different companies that had a variety of different types of construction projects occurring, primarily in the quality space.  I was able to work on building quality teams and on building quality systems, especially with companies at the stage of growing from small to medium, or medium to large. I also had the opportunity to be involved in some very serious remediation projects. I have been very fortunate throughout my career to have great role models and mentors. I have been able to begin building what is now a substantial network of professionals in the industry.  As I reflect now on all of those people that supported me, I am deeply committed to giving back by helping others.

Wow!  You have had a diverse and ever-evolving career!  What led you to where you are now?

In my most recent full-time industry position, I served as the head of quality for Vertex Pharmaceuticals, which is a rare disease company. Vertex is a high challenge, high demand, awesome place to be; it is where I started to really understand the gap between what we teach and how we teach it – and what is actually needed in the workplace. And so I left Vertex and started Partnership to Prosperity, with a dedication to work with employers, employees, and educators to ensure that job seekers develop the expertise employers need. The win-win of work-ready people benefits communities and employers, and I am certain that it is critical to have a modern workforce where business, educational, and social interests intersect to ensure all stakeholders prosper. 

How did you come to join PQE Group in the US?

It was through a Partnership to Prosperity engagement with Northeastern University that I met Doctor Willis Thomas, a PQE leader, who introduced me to PQE Group. PQE brings professional technical and leadership capabilities to its client engagements.  To do this, PQE has a commitment to providing important development, training, and support to its consultants to ensure they have the knowledge, skills sets, experience, and competencies to successfully support PQE’s clients. Which also means that when the PQE consultant completes a project, the client’s staff will have had the secondary benefit of professional development to continue the work that the PQE consultant worked on with them. Therefore, there is tremendous synergy with what I have been doing overall, and what PQE is doing to continue to evolve its growth in the US.

Leveraging my extensive network and experience developed over the past four decades, I am now working with PQE Group as a Principal Consultant and Networking Executive to help the company understand and serve the distinctive aspects of the US market. I find PQE is unique for a consulting firm, particularly when compared to the very large consultancies.  PQE can be considered a boutique organization that does an exceptional job of customizing its offerings to meet the client’s unique needs. The industry experience and deep understanding of the end-to-end product lifecycle I bring the client delivers high-value consulting. I fully believe that honesty, mutual respect, and candor are so important to a client, as is transparency and collaboration. Of course, knowledge, experience, and the ability to complete projects fully and in compliance with regulations are critical, as well as a sincere interest in the team and the project the consultant has been hired to support.  These attributes, I know, is what PQE Group provides, and why I am honored to participate in PQE Group’s US journey.

What are you most excited about in this role? What impact are you hoping to have in the next 6 months to a year?

I believe PQE Group is uniquely built to be much more agile, flexible, and adaptable.    PQE consultants approach their work from a context of servant leadership; as the advocates who have experience that is applied to a clients’ problem in a way that serves its stakeholders.  I’m here to help  clients understand the value-based benefits to working with PQE Group, because what we are talking about are very high stakes; if there was ever an industry where it is critical for clients to have the knowledge and capabilities from a consultant that specializes in quality areas, this is it. PQE and its consultants truly work for their clients; in the end, client reactions tend to be “wow – I got a great result from those guys.”  I’m excited to work with this unique organization, help promote its’ promise to prospective clients in the US, and truly provide value by using my experience to help industry understand PQE’s unique way of contributing significant value.

Based on your long and successful career, what is a major takeaway you have come to realize?

When I think back to those 40+ years, a key takeaway is that there was always someone that advocated for me; that helped me out.  Starting with Merck, I was consistently reminded by leadership teams that as good as we might be, every one of us had the benefit of someone looking out for us. It was expected that we do that, as well, in return – that was the culture at Merck and it made so much sense to me.  I’ve been fortunate to have had a really interesting career, one that has included different names, shapes, sizes, and flavors. This  has taught me how to be extremely resourceful, how to be sincerely considerate, and that the people that were – and still are - part of what I was or am doing at any given time have never lost track of who it is all being done for:  patients who have medical conditions, who desperately need relief and help with treatment. What we do every day is work to provide that to them! I truly believe those of us in this industry are so very lucky to be able to be in that type of a position.