Sri S. Challa's career is a testament to the power of determination, expertise, and a relentless pursuit of excellence. With a rich background in validation, quality management, and compliance across several top-tier organizations, Sri has made significant contributions to the field of life sciences and healthcare technology. His journey, marked by a diverse skill set and a series of impactful roles, provides valuable insights into the ever-evolving landscape of technology and regulatory standards. In this interview, Sri shares his experiences, challenges, and advice for aspiring professionals.
Q. Can you walk us through your educational background and how it laid the foundation for your career in technology and validation?
A. My educational journey has been instrumental in shaping my career. I began with a Bachelor's degree in Chemical Engineering and a Master of Science in Biological Sciences from BITS Pilani, Hyderabad. This dual degree program gave me a strong foundation in both engineering principles and biological sciences. Following that, I pursued a Master of Engineering in Biomedical Engineering from Rutgers University. This program was pivotal as it combined my interests in engineering and healthcare, providing a comprehensive understanding of biomedical technologies. Finally, I completed a Master of Science in Managing Information Technology with a focus on healthcare from Sullivan University. This diverse educational background equipped me with a unique blend of technical, scientific, and management skills, which have been crucial in my roles in validation and compliance.
Q. What inspired you to specialize in computer system validation and quality management?
A. My interest in computer system validation and quality management was sparked during my time at Gilead Sciences, where I was involved in the complete Software Development Life Cycle (SDLC). The intricacies of ensuring that systems met regulatory requirements and maintained high standards of quality fascinated me. This role allowed me to see the direct impact of effective validation on patient safety and product efficacy. Additionally, my educational background in biomedical engineering and IT management provided me with the necessary skills and knowledge to excel in this field. The blend of technical rigor and the need for meticulous documentation and compliance resonated with me, driving my passion for this specialization.
Q. Can you describe your current role at Celito Tech, Inc. and the responsibilities it entails?
A. At Celito Tech, Inc., I serve as the Computer System Validation Lead. In this role, I provide leadership and guidance on CSV initiatives, ensuring compliance with industry regulations such as 21 CFR Part 11, EU Annex 11, and ISO standards. My responsibilities include leading product design and development for manufacturing quality management and clinical data management systems. I manage client engagements, coordinate resources, and handle client communications and escalations. Additionally, I provide technical expertise and regulatory interpretation, author and review companywide policies, SOPs, and CSV deliverables, and collaborate with various functions to execute CSV activities using a risk-based approach. This role requires a comprehensive understanding of regulatory requirements and the ability to manage multiple projects simultaneously.
Q. What were some of the key projects you led at Verily Life Sciences, and what impact did they have?
A. At Verily Life Sciences, I was a Quality Lead for the Clinical Studies Platform (CSP) and the Laboratory Information Management System (LIMS). One of the key projects I led was the COVID-19 Testing Program in partnership with Rite AID, which involved conforming to CDC/HHS requirements. This project had a significant impact as it facilitated large-scale testing during the pandemic, contributing to public health efforts. Additionally, I improved the Computer System Validation process by introducing assessments for classifying GxP impact and validation rigor based on intended use and GAMP category. I also led risk management efforts, implemented security by design, and supported multiple partner-initiated audits, ensuring that Verily’s processes and procedures were robust and compliant.
Q. How did your experience at Illumina Inc. contribute to your expertise in validation and compliance?
A. At Illumina Inc., I served as an IT Quality and Compliance Analyst, where I led the implementation of ValGenesis, an electronic Validation Lifecycle Management System. This role involved designing and executing data migration strategies, conducting risk assessments, and managing various validation projects adhering to the SDLC process. I authored SOPs and conducted training sessions on validation lifecycle processes and good documentation practices. Additionally, I led cybersecurity assessments and implemented procedural controls for access management. These experiences deepened my understanding of validation and compliance, particularly in the context of large-scale, data-driven projects and reinforced the importance of meticulous planning and documentation.
Q. What were the major challenges you faced while working at Betteromics, and how did you overcome them?
A. At Betteromics, one of the major challenges was leading software validation activities for clinical and lab platforms, which involved risk assessments, supplier audits, and defect management. The dynamic nature of clinical trials and lab research required a flexible and adaptive approach. I addressed these challenges by implementing a risk-based approach to validation, revising procedures based on the latest GAMP5 guidance, and establishing a pre-approved change management process for high-risk infrastructure. Additionally, I collaborated closely with software, product, and testing teams throughout the SDLC, ensuring that validation activities were integrated seamlessly and efficiently.
Q. Can you share your experience with leading quality workstreams and launching clinical studies at Verily Life Sciences?
A. Leading quality workstreams at Verily Life Sciences was a highly rewarding experience. I was responsible for operational support, defect management, and new feature launches for the Clinical Studies Platform (CSP) and Laboratory Information Management System (LIMS). One of the notable projects was the COVID-19 Testing Program, which required close coordination with various stakeholders and compliance with stringent regulatory requirements. I authored validation plans, protocols, and test reports, managed testing activities, and led risk management efforts. These initiatives not only ensured the quality and reliability of Verily’s platforms but also played a crucial role in supporting public health initiatives during the pandemic.
Q. How has your involvement with professional organizations like ASQ and ISPE influenced your career?
A. Being a member of professional organizations like the American Society of Quality (ASQ) and the International Society for Pharmaceutical Engineering (ISPE) has significantly influenced my career. These organizations provide valuable resources, networking opportunities, and platforms for continuous learning. Through ASQ, I have gained insights into best practices in quality management and validation. ISPE has provided me with a deeper understanding of the pharmaceutical engineering landscape and regulatory requirements. Participating in events, workshops, and discussions within these organizations has allowed me to stay updated with industry trends and standards, enhancing my professional growth and expertise.
Q. What advice would you give to professionals aspiring to excel in computer system validation and quality management?
A. For professionals aspiring to excel in computer system validation and quality management, my advice would be to focus on building a strong foundation in both technical and regulatory aspects. Understanding the principles of validation, risk management, and compliance is crucial. Gain hands-on experience through internships or projects and pursue relevant certifications. Additionally, developing strong communication and collaboration skills is essential, as these roles often involve coordinating with various stakeholders. Stay curious and committed to continuous learning, as the field is constantly evolving. Lastly, be meticulous and detail-oriented in your work, as accuracy and thorough documentation are critical to ensuring compliance and quality.
Q. What are your future aspirations and goals in your career?
A. My future aspirations involve continuing to advance in the field of computer system validation and quality management, focusing on leadership roles where I can drive strategic initiatives and innovation. I am passionate about mentoring and guiding the next generation of professionals in this field, sharing my knowledge and experiences to help them navigate their careers. Additionally, I aim to contribute to the development of industry standards and best practices through active participation in professional organizations and committees. Ultimately, my goal is to make a meaningful impact by ensuring that technology and healthcare solutions are safe, effective, and compliant, thereby improving patient outcomes and advancing the industry.
Sri S. Challa’s journey through the realms of validation and compliance is a story of dedication, expertise, and continuous growth. His diverse experiences and roles at leading organizations have equipped him with a profound understanding of the complexities and challenges in the field. As he continues to push the boundaries of quality management and validation, Sri remains committed to improving industry standards and mentoring the next generation of professionals. His story serves as an inspiration for those looking to make a significant impact in the world of technology and healthcare.
