Ashita Chauhan
Ashita Chauhan is a regulatory affairs and quality assurance professional specializing in cell and gene therapy, with more than six years of experience supporting cancer research and patient safety in highly regulated laboratory environments. Based in Boston, she currently serves as a Compliance Technical Specialist at Beth Israel Deaconess Medical Center, where she leads quality assurance efforts for a cancer research laboratory working with sensitive patient products. In her role, Ashita oversees internal audits, document control systems, staff training, compliance-related SOP development, and regulatory readiness while serving as the primary point of contact during FDA and FACT inspections. She has successfully supported more than ten external audits without any major findings, reflecting her strong commitment to operational excellence, regulatory integrity, and patient-centered care. Her work ensures that laboratory processes remain compliant, contamination-free, and aligned with the highest standards in cellular therapy and clinical research. Ashita earned her bachelor’s degree in pharmacy from Nirma University, India before completing a Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices at Northeastern University with a concentration in international regulatory affairs. Throughout her career, she has developed expertise in FDA regulations, cGMP environments, quality systems, CAPA management, risk assessments, and FACT accreditation standards for immune effector cell therapies and CAR-T clinical trials. Known for her detail-oriented approach and strong analytical skills, she has written and reviewed numerous quality procedures, validation plans, and compliance protocols while mentoring/training laboratory staff on regulatory best practices. In addition to her technical accomplishments, Ashita has earned multiple professional certifications and remains actively engaged in ongoing education and industry innovation, including discussions surrounding artificial intelligence in quality assurance. Beyond her professional responsibilities, Ashita is deeply committed to advocacy, mentorship, and community engagement. She volunteers with the American Cancer Society and the Foundation for the Accreditation of Cellular Therapy while also serving as a co-op alumni mentor at Northeastern University, where she helps guide students as they begin their careers in healthcare and life sciences. Her dedication to mentorship and education led to her being featured on a Northeastern alumni podcast discussing her professional journey and experiences in regulatory compliance. Driven by a passion for protecting cancer patients and advancing safe laboratory practices, Ashita approaches her work with integrity, continuous curiosity, and a strong belief that quality and compliance are essential to delivering meaningful outcomes in modern healthcare and biotechnology.
• 16 certifications in AI and related fields
• Nirma University
Bachelor's degree in Pharmacy, Student in institute of Pharmacy
• Northeastern University
Masters, Master of science in Regulatory Affairs for Drugs, Biologics and Medical Devices
• International Society for Cell and Gene Therapy (ISCT)
• Foundation for Accreditation of Cell Therapy (FACT)
• American Cancer Society volunteer
• Co-op Alumni Mentor at Northeastern University
• Foundation for Accreditation of Cell Therapy (FACT) volunteer
What do you attribute your success to?
I would say my success comes from a combination of dedication, curiosity, and taking real ownership of my work. I don’t just complete tasks-I try to understand the “why” behind them and look for ways to improve processes.
When challenges come up, I don’t step away from them. I take responsibility, dig deeper to understand the root cause, and make sure they are resolved properly. That mindset has helped me grow and build confidence in my work.
What truly drives me is the impact on patients. Knowing that even small details matter in ensuring patient safety keeps me focused, detail-oriented, and motivated to keep learning and improving every day.
What’s the best career advice you’ve ever received?
If you don’t like a rule, master it first, then change it. Real impact comes from understanding the system before trying to improve it.
What advice would you give to young women entering your industry?
I would say don’t give up, even when things feel overwhelming. Be patient with your growth and focus on learning as much as you can. Speak up, ask questions, and don’t be afraid to make mistakes, just make sure you learn from them.
Also, find mentors and build a support system. And most importantly, always keep patient safety first-when your work is driven by purpose, everything else starts to align.
What are the biggest challenges or opportunities in your field right now?
One of the biggest challenges in my field is maintaining absolute precision in a highly regulated, patient-focused environment where there is little to no room for error. It requires constant attention to detail, strong documentation practices, and staying continuously updated with evolving regulations and guidelines. Another challenge is managing increasing complexity-whether it’s new technologies, advanced therapies like cell and gene therapy, or large volumes of data that need to be accurate and audit-ready at all times.
At the same time, these challenges create significant opportunities. There is a strong push toward innovation, including digitalization and the use of AI in quality systems, which can improve efficiency and decision-making. It’s also a field that encourages continuous learning, cross-functional collaboration, and professional growth. For me, it’s an opportunity to not only strengthen my technical expertise but also contribute to building more efficient and future-ready quality systems.
What values are most important to you in your work and personal life?
The values that matter most to me, both in my work and personal life, are dedication and continuous learning. I believe in staying committed to what I do and constantly improving myself. If something isn’t working, I take it as an opportunity to learn, identify what went wrong, and come back with stronger solutions. Persistence is important to me—I don’t give up easily, and I always strive to grow from challenges.
Locations
Beth Israel Deaconess Medical Center
330 Brookline Avenue, Boston, MA 02215