Exploring what drives quality leaders to think differently.

Purna’s  career spans Pfizer, Novartis, and UPenn— and who now leads his own software company.

Purna speaks about quality with a mix of logic, humility, and heart. His journey — from a curious child in India to senior roles across quality, auditing, and compliance — reflects upon a career built on curiosity, connection, and integrity.

As a boy, Purna admits he “wasn’t a great student,” more interested in cricket and exploration than memorization. That changed when a college professor introduced him to logic in a way that clicked — sparking a lifelong fascination with how systems work and why they matter.

Professionally, that curiosity evolved into a deep respect for FDA regulations. His passion for compliance is rooted in understanding the purpose behind every rule and process.

Reflecting on his career, Purna sees each chapter — from large pharmaceutical companies to smaller startups — as essential. The high-pressure “firefighting” phases, he says, were often when he grew the most.

When discussing challenges, Purna highlights communication and cultural context as key hurdles — learning to translate technical complexity into shared understanding. His greatest reward, he says, comes from solving problems.

Now, as the founder of a software company, he builds systems intended to force users to comply with the US FDA CGMP Pharmaceutical Drug regulations whilst remaining measured when using AI: “Commercial AI tools pull from the internet, not from the regulations. They can assist, but they can’t replace human judgment. You still need someone who knows the CGMP regulations — and always go back to the source.”

Asked what advice he’d give to those starting out in quality, Purna doesn’t hesitate:

“If the FDA regulations aren’t met, the product is considered adulterated. To do quality work, you must understand and comply with the regulations.”

Purna is an advocate for transparency and traceability when sharing his interpretation of the regulations through LinkedIn posts: “I always include the reference — people should be able to go back and check for themselves.” 

To learn more about Purna’s US FDA CGMP interpretation, follow or connect with Purna, on LinkedIn: https://www.linkedin.com/in/purna-thakker-165a404/

Meeting at the Carnegie Center, Princeton, 17 Oct 2025