Isha Patel on the Overnight Career Plan That Took Her from Associate Director to SVP

Naymisha (Isha) Patel has spent thirty years in Quality and regulatory compliance across pharmaceuticals, biologics, medical devices and combination products. She is now Senior Vice President of Quality at AirNexis Therapeutics, a seven-month-old startup developing a combination product for COPD, where she is the first Quality hire.

In this episode Isha talks about the ten-year career plan she wrote overnight in 2005 after a hiring VP at Nektar asked what she wanted, and how it carried her from associate director to senior vice president. She explains why she moved to Boston in a blizzard to lead Quality at Ocular Therapeutix, a one-product company with two FDA complete response letters, and what she found in the inspection scribe notes. She walks through the reorganisation, letting go of people whose skill sets did not match the product classification, and the FDA inspection that ended in approval with no post-approval commitments. Isha also covers building Tenaya's Quality function, closing that same manufacturing facility four and a half years later, and choosing between consultants and permanent headcount.

Topics covered:

- Why a career plan written on paper beats a vague ambition

- Reading the scribe notes, not just the CRL

- Letting people go for skill fit, not performance

- What FDA inspectors want to see when you are not finished

- Green flags when a CEO hires their first head of Quality

- Consultant or permanent hire: the two-year vision test

- Why Quality is missing from early-stage boards

- Quality as navigating grey zones, not yes or no

Timestamps:

(00:00) Introduction and guest background

(02:52) Transitioning into Quality leadership

(06:34) Career moves and a pivotal opportunity

(08:38) A practical career plan

(13:13) Turning around a Quality system

(20:21) Building Quality in gene therapy

(22:14) Choosing the right startup role

(25:42) Building a lean Quality team

(28:09) C-suite and board aspirations

(30:10) Advice for aspiring Quality leaders