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Gururaj Vinekar

AI Transformation | Senior Manager – Life Sciences CSV, CSA & SaMD | Process Re-engineering | Digital, Automation & GxP Strategy | Program Leadership

Greater Bengaluru Area

13+ years of work experience

PwC India
Feb 20268 mosPresent

Greater Bengaluru Area

EY
Apr 20241 yr 11 mosFeb 2026

Greater Bengaluru Area

EY
Feb 20222 yrs 2 mosMar 2024

Greater Bengaluru Area

EY
Aug 20217 mosFeb 2022

Bengaluru, Karnataka, India

Deloitte India (Offices of the US)
Sep 20182 yrs 11 mosJul 2021

Bengaluru Area, India

Deloitte India (Offices of the US)
Aug 20162 yrs 2 mosSep 2018

Bengaluru, Karnataka, India

TechGuru Web Solutions
May 20133 yrs 3 mosJul 2016

Greater Bengaluru Area

Education

Atria Institute of technology

B.E Computer Science

Atria Institute of technology

20124 yrs2016

Secondary School

Sri Sathya Sai Vidya Kendra Muddenahalli

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Headline

AI Transformation | Senior Manager – Life Sciences CSV, CSA & SaMD | Process Re-engineering | Digital, Automation & GxP Strategy | Program Leadership

About

With over 9 years of experience spanning CSV - Computer System Validation, regulatory compliance, and quality management in the Life Sciences Industry, I bring a unique blend of technical expertise and strategic vision. Having successfully led validation projects for life sciences and pharma giants, I’ve ensured seamless adherence to regulatory standards, including FDA 21 CFR Part 11, GxP, and ISO norms. In my role as a CSV leader, I’ve spearheaded the validation of RPA BOTs, reducing operational FTEs while navigating audits and inspections from internal stakeholders and regulatory bodies. My ability to bridge the gap between technology and compliance has consistently delivered results that drive efficiency, mitigate risks, and uphold quality standards. Simultaneously, my passion for product and project management has led me to dive deep into Generative AI and automation solutions. I leverage cutting-edge technologies to streamline processes, improve decision-making, and deliver business impact. I believe in marrying regulatory rigor with the agility of modern technology to unlock innovative solutions for highly regulated industries. I thrive at the intersection of process transformation, AI-driven innovation, and quality-focused execution. Whether managing cross-functional teams or designing scalable solutions, I’m motivated by a desire to create value and drive meaningful change. Let’s connect to discuss opportunities where technology, compliance, and innovation meet!

Location

Greater Bengaluru Area

Work experience

Senior Manager at PwC India, Feb 2026 - Present · 8 mos, Greater Bengaluru Area

Manager at EY, Apr 2024 - Feb 2026 · 1 yr 11 mos, Greater Bengaluru Area

Senior Consultant at EY, Feb 2022 - Mar 2024 · 2 yrs 2 mos, Greater Bengaluru Area

Consultant at EY, Aug 2021 - Feb 2022 · 7 mos, Bengaluru, Karnataka, India

Associate Solution Advisor at Deloitte India (Offices of the US), Sep 2018 - Jul 2021 · 2 yrs 11 mos, Bengaluru Area, India

Advisory Analyst at Deloitte India (Offices of the US), Aug 2016 - Sep 2018 · 2 yrs 2 mos, Bengaluru, Karnataka, India

Founder at TechGuru Web Solutions, May 2013 - Jul 2016 · 3 yrs 3 mos, Greater Bengaluru Area

Education

B.E Computer Science, Atria Institute of technology

Secondary School, Sri Sathya Sai Vidya Kendra Muddenahalli

Gururaj Vinekar - Senior Manager in Greater Bengaluru Area | Tal