Shipra Pachori
Shipra Pachori is a seasoned Quality Assurance and Computer System Validation (CSV) leader with over 14 years of experience across the software, biotechnology, pharmaceutical, and medical device industries. She specializes in validation and qualification, commissioning, GxP documentation, and end-to-end project delivery, with expertise aligned to FDA, Annex 11, 21 CFR Part 11, and GAMP 5 standards. With an MBA and strong Agile project management experience, Shipra combines strategic thinking with hands-on execution, driving process improvement, risk management, and cross-functional stakeholder collaboration. Throughout her career, Shipra has led global validation initiatives, system implementations, and change control programs that strengthened audit readiness, improved data integrity, and reduced compliance risk. She began her career as a software tester and advanced into validation and commissioning leadership roles across diverse business domains. Her professional background includes work with leading organizations such as Amgen and PBS Biotech, where she contributed to validation and compliance initiatives supporting advanced bioreactor manufacturing and regulated systems. Known for her disciplined, transparent, and collaborative leadership style, Shipra values honesty, clear communication, and structured execution while promoting mental health and work–life balance within high-performance teams. Outside of work, she enjoys traveling, camping, spending quality time with her family, and connecting with friends through fun girls’ nights. She is passionate about contributing to organizations that prioritize innovation, quality culture, and regulatory excellence.
• ISTQB
• Devi Ahilya Vishwavidyalaya - MBA, Finance and Marketing
What do you attribute your success to?
I attribute my success to honesty, clarity, and discipline, combined with a strong focus on mental well-being. Being transparent and consistent in my communication has helped me build trust with colleagues and stakeholders, while maintaining discipline has allowed me to sustain and grow my career over time.
What’s the best career advice you’ve ever received?
The best career advice I’ve received is to stay proactive, anticipate challenges, and communicate clearly. Doing so consistently builds trust, drives results, and opens doors for growth.
What advice would you give to young women entering your industry?
Make sure to keep a healthy work-life balance and don’t let work spill into your personal life. Be patient with your career growth—don’t chase titles too quickly, focus on gaining experience and the right opportunities will come.
What are the biggest challenges or opportunities in your field right now?
Challenges in the current job market include limited job security due to high turnover and layoffs, slower hiring driven by economic and political uncertainty, reduced investment in continuous improvement resulting in increased workloads, and less transparent hiring processes, including delayed communication from recruiters, which can impact candidates’ experiences.
What values are most important to you in your work and personal life?
Honesty and discipline are paramount, but equally important is protecting your mental health, maintaining balance, staying adaptable, and consistently showing resilience—these are the foundations for long-term success.
Locations
Newbury Park, CA 91320