# 066 -Scientist to CSO, Learning QA/RA & Marketing, and Saying Yes to Oppurtunities with Fran DeGrazio

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-01-04
- Length: 55m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-04-066-scientist-to-cso-learning-qa-ra-marketing-and-saying-yes-to-oppurtunities-wi
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/066--Scientist-to-CSO--Learning-QARA--Marketing--and-Saying-Yes-to-Oppurtunities-with-Fran-DeGrazio-e1st28i

## Summary

Fran DeGrazio, President of Strategic Parenteral Solutions and former Chief Scientific Officer at West Pharmaceuticals, discusses the complexities of combination products, highlighting the historical silos between science and engineering. She explains how regulatory frameworks like ICH Q8-Q10 and Quality by Design (QbD) have shifted the industry toward risk management and lifecycle management, which she identifies as a major struggle for smaller organizations. DeGrazio also shares her career trajectory at West, detailing her transition from laboratory roles to leading Quality, Regulatory, and Marketing, emphasizing the importance of strategic execution and continuous learning.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-04-066-scientist-to-cso-learning-qa-ra-marketing-and-saying-yes-to-oppurtunities-wi#t=0) Introduction: Subi Saadeh and Fran DeGrazio
- [2:13](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-04-066-scientist-to-cso-learning-qa-ra-marketing-and-saying-yes-to-oppurtunities-wi#t=133) The Science vs. Engineering Divide in Combination Products
- [5:05](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-04-066-scientist-to-cso-learning-qa-ra-marketing-and-saying-yes-to-oppurtunities-wi#t=305) Strategic Consulting and Regulatory Intelligence
- [10:49](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-04-066-scientist-to-cso-learning-qa-ra-marketing-and-saying-yes-to-oppurtunities-wi#t=649) Risk Management and Quality by Design (QbD)
- [16:02](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-04-066-scientist-to-cso-learning-qa-ra-marketing-and-saying-yes-to-oppurtunities-wi#t=962) Lifecycle Management Challenges for Smaller Organizations
- [17:54](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-04-066-scientist-to-cso-learning-qa-ra-marketing-and-saying-yes-to-oppurtunities-wi#t=1074) Leadership at West Pharmaceuticals: Communication and Culture
- [23:11](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-04-066-scientist-to-cso-learning-qa-ra-marketing-and-saying-yes-to-oppurtunities-wi#t=1391) Career Journey: From QA Labs to Chief Scientific Officer
- [29:57](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-04-066-scientist-to-cso-learning-qa-ra-marketing-and-saying-yes-to-oppurtunities-wi#t=1797) Building a Contract Lab for Extractables and Leachables
- [39:31](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-04-066-scientist-to-cso-learning-qa-ra-marketing-and-saying-yes-to-oppurtunities-wi#t=2371) Saying Yes to Opportunities and Career Advice

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Scaling production](https://hardwarepodcasts.com/topic/scaling-production)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)

## Most relevant to

large enterprises, early-stage companies

## Mentioned

- West Pharmaceuticals (company)
- Strategic Parenteral Solutions (company)
- ICH Q8 (other)
- ICH Q9 (other)
- ICH Q10 (other)
- TCS (other)
- Good to Great (other)

## Related episodes from other shows

- [#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment) (Global Medical Device Podcast)
- [#323 The Combination Products Handbook](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook) (Global Medical Device Podcast)
- [#380: Navigating the Complex World of Combination Products with Subhi Saadeh](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-30-380-navigating-the-complex-world-of-combination-products-with-subhi-saadeh) (Global Medical Device Podcast)
- [#440: ICYMI (In Case You Missed It!) Fundamentals of Quality & Regulatory](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-05-440-icymi-in-case-you-missed-it-fundamentals-of-quality-regulatory) (Global Medical Device Podcast)
- [#352: Fundamentals of Quality & Regulatory](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-01-18-352-fundamentals-of-quality-regulatory) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-04-066-scientist-to-cso-learning-qa-ra-marketing-and-saying-yes-to-oppurtunities-wi. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Let's Combinate.