Pujitha Gourabathini wants to see how QMSR has affected you

RAPS Convergence is where the world’s regulatory affairs community gathers to share expert insights and create meaningful connections. We’re talking to the speakers behind this year’s event to get the inside scoop on the topics everyone will be talking about and their tips for making the most of your week. Next up: Pujitha Gourabathini, quality assurance manager at BD. 

What is your current role and what does it entail? 

I'm a quality assurance manager at BD specializing in risk management. My team specifically focuses on premarket risk management, which means we work on sustaining changes, new product development, production, and everything before market release. I'm with the medication management solutions business unit, which consists of our infusion pumps and dispensing cabinets. 

You started your quality career as a quality engineer — risk management SME. Now you are a quality assurance manager, risk management. How have you seen your quality knowledge grow in that time? 

I want to say risk management, but a lot of my knowledge also grew around the quality management system itself. Earlier in my career, I was very focused on product risk management. I was focused on how products could cause patient harm if something went wrong. I was always trying to answer: how can we design this out in terms of risk control measures, or how can we do a hazard analysis? 

With the advent of QMSR and EU MDR, my focus has turned to risk-based decisions across not just the product, but also across the lifecycle of the quality system. Earlier in my career when I worked in the implementation phase, I was very focused on product safety. Now, I've also gotten more insight into product security and how that links to safety.

What role has the QMSR played in your own professional development? 

With QMSR, my professional development has been more cross-functional. Instead of just talking to the team that's involved in developing a product, now I’m talking with the team that's involved in the complaints analysis and CAPAs, as well as in supplier quality and in operations. Professionally, QMSR has helped me grow by helping me meet so many new people in roles I was not as familiar with before. 

How did this session come to be? 

Late last year and early this year, all the manufacturers were busy doing gap assessments and trying to see where they were with QMSR as it went into effect. Everyone was wondering: how did we do compared to everyone else? You cannot address all aspects of QMSR at the same time. One must prioritize. I want to see how the ideas I came up with compared to what someone else came up with. 

What made you interested in presenting at a Solutions Circle? 

I wanted to learn from other manufacturers. I am excited to see how they've addressed QMSR at their organizations and what gaps they have seen. Did they do a holistic revamp of their quality system? Did their ISO 13485 compliance really translate 100% into QMSR? Learning from others' experiences, along with sharing what we've experienced and explaining our strategy, is what I’m most excited for. 

Why did you decide to attend RAPS Convergence this year? 

I started being active on LinkedIn last year. I wanted to contribute to the industry by sharing what I've learned so far in my career. I was following other quality professionals in LinkedIn, and I saw a lot of them share posts about their experience at RAPS Convergence 2025 in Pittsburgh. 

I saw so many posts about it and read so many posts about the sessions my connections attended. As I was looking through the sessions and saw which of my colleagues attended it, I realized that there were a lot more quality professionals in attendance than I realized. 

The sessions they were talking about were very closely related to what I do. They weren’t just, “How do we create a submission?” So many people are RAQA, not just regulatory, and not just quality. 

What are you excited for at your first RAPS Convergence? 

I think RAPS Convergence will be a good segue for me to learn more about the overlap of quality and regulatory. I think this will help me continue to collaborate with regulatory affairs professionals, and it'll give me a great look at what's happening in the industry. I am also attending with a couple of industry professionals I know outside of work. I'm excited to meet up with them because we don't get to see each other in person very often.