Executive Director, IT Quality and Compliance, Gilead Sciences

Ken Shitamoto leads the IT Quality and Compliance group at Gilead Sciences, which includes Privacy, Quality Assurance and Quality Engineering. He is a member of the GAMP America’s Steering Committee, Co-Lead of the GAMP CSA SIG, and a member of the FDA-Industry CSA team. He is contributing author to GPG Data Integrity by Design (CSA Appendix), GPG Enabling Innovation, and GAMP5 v2.

He holds a BA Molecular Cell Biology and MS Computer Science and from UC Berkeley and San Jose State University respectively.

AVP & Head – IT, ERIS Lifesciences.

Dr.Mukund KS (DLitt) is a Distinguished Global CIO Certified (ISB) Technology and Business Visionary, with Executive Hands-On experience in Heading End-To-End IT, Digital Transformation, Infrastructure, Governance & Security, ERP & CRM Programs.

Endowed with Rich & Diversified Industry Experience spanning over 20+ years, across various Industries, Domains and Geographies. A Strategist proficient at fragmenting Corporate Objectives into actionable technical programs, solutions and systems through Innovative means of Simplification, Automation, Design Thinking and Digital Transformations to maximize revenues and profits.

A fiscally conscious Technology Evangelist focused on Rapid-ROI backed Initiatives / Programs with Documented and Quantified Business Benefits.

Visionary thinker with entrepreneurial attitude, an inspirational leader and outstanding team player, creates robust strategies through a collaborative approach translating vision into achievement.
People’s leader, responsible for Motivating Global Teams for top achievements and retaining High value Diversified IT Talent Globally.

A Charismatic Communicator and Speaker easily interfaces with C-Level Executives and across various lines. A winner of multiple awards and recognition’s for Global Deployments. Mentor for start-ups and students.

 

Principal Consultant, Lachman Consultant Services

Pat is an established pharmaceutical executive and practitioner with proven leadership in proactive risk identification, deployment of strategies to enhance compliance controls, and implementation of detection systems to eliminate blind spots. He is skilled in policy deployment, Computer System Validation, Data Integrity/Governance, Risk Management, Supply Chain Logistics and application of AI for the next generation of quality professionals. He has trained FDA field inspectors for facility inspection techniques and has delivered talks on deployment of risk strategies and modern signal detection. His expertise also includes outsourcing and integrating efficient governance of Facilities Management and laboratory services across US/UK and Asia-Pacific. Pat’s frequent blogs and articles help educate the industry become aware of emerging global risks, technologies, and their effect on the global supply chain.

Associate Director, R&D Quality Lead, Bristol Myers Squibb (BMS)

Souvik is a results-driven quality professional and digital-innovation enthusiast with over 20 years of expertise in Good Vigilance Practice (GVP), Good Clinical Practice (GCP) and Information Technology Quality Assurance (ITQA). He has led more than 200 GCP/GVP audits across America, Europe, Middle East, Africa and Asia, and has steered high-profile inspections by regulators including the US-FDA, MHRA and BfArM. His career spans leadership roles at Novartis, Sciformix (now Fortrea), Hetero, Lupin and Tata Elxsi. Currently he is leading Research and Development Quality for Bristol Myers Squibb’s GCC India operations.
By training, Souvik holds a PhD in Molecular Microbiology from Jadavpur University (in collaboration with the University of Texas, San Antonio), an MBA in Operations and a Postgraduate Diploma in Statistics. He is certified as a Project Management Professional (PMP), Agile Coach and Lean Six Sigma Black Belt, and serves as a Lead Auditor for ISO 9001:2015 (Quality Management) and ISO 27001:2022 (Information Security).

Director- Computer System Validation, Arcolab Private Limited.

With over two decades of experience in Computer System Validation, Computer Software assurance, regulatory compliance, and data assurance & reliability, Kiran brings deep expertise in risk-based validation strategies within Agile SDLC frameworks. He has successfully collaborated with leading global organizations including Apotex, Cipla, Eurofins, Novo Nordisk, Ranbaxy, Eisai, and Strides. His capabilities span manufacturing and laboratory systems, infrastructure qualification, and cloud-based validation solutions.
He has played a pivotal role in guiding teams by integrating CSA approaches to enhance validation efficiency, championing Data assurance and reliability programs which has resulted in the digital transformation initiatives.
His practical knowledge ensures the highest standards of compliance and operational efficiency in diverse, high stakes environments.

 

 

Chief Quality Officer, Aurobindo Pharma.

Dr. A. Rama Mohana Rao has honoured with Ph.D. in Pharmaceutical Analysis from Andhra University in 1988. He was awarded for best thesis in the year of 1987 – 88 from Andhra University. Before moving to Aurobindo, he worked with Ranbaxy laboratories Limited, Cadila Pharmaceuticals and Biological E. Limited in senior positions.

Since 2001, Dr. A. Rama Mohana Rao has been working with Aurobindo Pharma Ltd, he has total experience of 32 years in various disciplines of Pharma and Biological industry including Quality, Regulatory. R&D, Manufacturing operations.

Now, Dr. A. Rama Mohana Rao has been positioned as Chief Quality Officer, looking after Global Quality and Drug safety operations of Aurobindo Pharma. Dr. A. Rama Mohana Rao has designed and implemented many Quality Policies and Procedures across the company. He is instrumental in the implementation of various quality and manufacturing systems digitalization/Automation in the company. He has expertise in API, Oral and Injectables. He has successfully handled more than 100 regulatory inspections such as USFDA, MHRA, ANVISA etc. He is also an award winner of the Sustainable Advocate, recognizing his commitment to sustainable practices in the pharmaceutical industry.

Senior Director – Quality, Emcure Pharmaceuticals

Chetananad Pathak is a seasoned pharmaceutical quality leader with over 28 years of experience across sterile and non-sterile APIs, oral formulations, and injectables. Currently serving as the Senior Director – Quality at Emcure Pharmaceuticals, he oversees corporate quality and compliance functions, ensuring global regulatory alignment and operational excellence.

Chetananad holds a Master’s degree in Microbiology and is a certified Six Sigma Green Belt. His expertise is backed by multiple credentials in leadership, critical thinking, and digital transformation. Over the years, he has led and managed inspections from top regulatory bodies including the USFDA, MHRA, ANVISA, TGA, and WHO.

Beyond operations, he has played a key role in vendor qualification programs, QAMS implementation, and API contract manufacturing oversight. He is also the author of “Hired”, a practical book offering insights and preparation tips for young professionals entering the job market.

Chetananad brings not just experience—but a deep commitment to fostering a quality-first culture in the pharma ecosystem.

 

Head – Information Technology, Inventia Healthcare Ltd.

Sanjay Nandavadekar is a passionate Information Technology executive with more than 20 years of experience in the Manufacturing – Pharmaceutical industry. Sanjay’s strategic leadership and certified skills in managing IT strategy, business process optimization, and creating a culture of cross-functional teams and his experience in SDLC have helped organizations achieve greater automation, efficiency improvements, and technology leadership using technology as a catalyst.

Sanjay has a proven track of leadership expertise in managing large enterprise projects targeted for process improvement, compliance, and greater ROI. His business relations with the vendor ecosystem and peer CIO network are helping him to stay abreast of technology trends. Sanjay is leading a portfolio of implementing cutting-edge technologies like Industry 4.0 (AI, IoT, RPA, Chatbot, NLP, BI, and Cloud) and has demonstrated the skill of owning high-volume budgets. Sanjay is a well-recognized individual in the industry and has received good recognition, and awards during his stint.

Principal eCompliance Specialist, Dr. Reddy’s Laboratories.

Yogesh C. Jagtap brings over two decades of deep expertise in Computer System Validation (CSV) and IT Quality Assurance, with a distinguished career spanning global consulting and leadership roles. He has spent 20 years in the field, including 8 years providing international CSV consulting to leading pharmaceutical and life sciences organizations.

His career includes pivotal roles at renowned Indian pharmaceutical companies like Ranbaxy, as well as global consulting firms such as Deloitte Touche Tohmatsu. Currently, he serves as the Global CSV Lead at Dr. Reddy’s Laboratories, where he manages the company-wide CSV/IT compliance program, ensures its conformance across the organization, and strives to keep it aligned with evolving regulatory expectations. He is committed to optimizing the compliance framework to balance IT regulatory requirements with the company’s digital transformation goals.

Sr. Director, Cognizant – Life Sciences Quality Engg. & Assurance.

Vinod brings over 24 years of leadership experience in the software industry, specializing in global delivery, transformation consulting, and quality engineering. As the Portfolio Delivery Lead for Cognizant’s Life Sciences QA division, he has successfully led large-scale transitions, Agile and DevOps transformations, and the establishment of Test and Quality Centers of Excellence across multiple global engagements. He is a recognized strategist in quality assurance, known for defining enterprise-wide QA frameworks, metrics, and governance models that drive measurable improvements in time-to-market and product quality. Vinod has authored several thought leadership papers on AI and automation, including “One Digital,” “AI-Driven Automated Failure Analysis & Resolution,” and “Intelligent AI – Driven through AI Hub.” A passionate advocate for innovation, Vinod is a frequent speaker at industry forums and holds certifications in Agile and Project Management. He earned his Bachelor of Engineering degree and continues to champion the integration of AI and GenAI into enterprise QA platforms.

Associate Director, Cognizant – Life Sciences Quality Engg. & Assurance

With nearly two decades of experience in the Quality Engineering domain, Kumaresan Lakkapuram Murugesan has been instrumental in driving transformation for Pharma clients. He has helped modernize validation processes by integrating tools, automation, artificial intelligence (AI), and Computer Software Assurance (CSA).Kumaresan has played a pivotal role in collaborating with large enterprise customers to adopt CSA and implement technological transformation initiatives. His strategic contributions have enabled organizations to optimize costs, accelerate validation cycles, and significantly enhance overall quality and compliance.

 

Director – Enterprise Platforms & Programs | Technology Site Leadership, AMGEN

With over 21 years of international leadership experience, Sushil Pathak has been at the forefront of designing, building, and scaling enterprise platforms that deliver measurable business impact. He specializes in technology strategy, large-scale transformation programs, and establishing Global Capability Centers (GCCs) and Centers of Excellence (COEs) across APAC, Europe, the US, and the UK.
Sushil has led multi-million-dollar global initiatives across life sciences, manufacturing, CPG, oil & gas, and BFSI—driving operational transformation, accelerating growth, and enabling sustainable innovation.
With leadership roles at Amgen, Reckitt, and Heubach, Sushil blends vision with execution to deliver measurable business impact.

 

SVP & CIO, Matrix Pharma Corp.

Krisna Sai T is a seasoned technology leader with over two decades of experience driving digital transformation, IT strategy, and enterprise innovation in the pharmaceutical and life sciences sector. As Senior Vice President & Chief Information Officer at Matrix Pharma Corp, he spearheads the organization’s technology vision — building scalable IT infrastructures, modernizing operations, and enabling business growth through digital excellence.

Prior to Matrix Pharma, Krisna Sai played a pivotal role at Biocon Biologics, where he successfully led the Global SAP Center of Excellence and IT Infrastructure. His expertise spans IT project and program management, SAP solution design, business process optimization, and enterprise digital strategy, making him a recognized voice in aligning IT with core business objectives.

A strong believer in leveraging technology as a growth enabler, Krisna Sai has been instrumental in fostering organizational efficiency, innovation, and resilience. His leadership has been recognized with multiple industry awards, reflecting his contribution to pushing the boundaries of IT in the bio-pharmaceutical domain.

At industry forums, Krisna Sai shares thought-provoking perspectives on digital transformation, future-ready IT ecosystems, and the evolving role of CIOs in driving business value.