Stephanie Cook
About Stephanie Cook
Stephanie Cook is the Director & Section Head of Digital Compliance at Procter & Gamble, with extensive experience in the development and validation of GxP-regulated computerized systems.
Current Role at Procter & Gamble
Stephanie Cook currently holds the position of Director & Section Head, Digital Compliance at Procter & Gamble. She has been in this role since 2020. Her responsibilities include overseeing the digital compliance strategies and ensuring adherence to regulatory requirements. With a strong focus on managing compliance in digital systems, she plays a vital role in maintaining the integrity and reliability of P&G’s digital infrastructure.
Previous Roles at Procter & Gamble
Before her current position, Stephanie worked as a Regulated Systems Compliance Leader at Procter & Gamble from 2018 to 2020. Located in Mason, Ohio, her role involved leading the compliance of regulated systems, ensuring all processes met industry standards. Her tenure at Procter & Gamble has been marked by her leadership in digital compliance and her focus on conforming to regulatory frameworks.
Experience at Medpace
Stephanie Cook had a significant career at Medpace before joining Procter & Gamble, where she served in various roles from 2004 to 2018. Notably, she was the Associate Director/Director, System Validation & Compliance from 2014 to 2018, and Manager/Senior Manager, System Development from 2006 to 2014 at Medpace Reference Laboratories. Earlier, she worked as a Software Engineer/Senior Software Engineer from 2004 to 2006 in the same lab. Throughout her tenure at Medpace, she specialized in system validation and compliance, contributing to the development of robust and compliant systems.
Early Career
Stephanie Cook began her career as a Software Developer at PPD (formerly MRL) in Northern Kentucky from 1998 to 2004. Prior to this, she worked as a Software Engineer at Mattel in Murray, Kentucky from 1996 to 1998. These early roles laid the foundation for her expertise in software development and compliance, which has been a critical aspect of her career trajectory.
Education
Stephanie Cook attended The University of Queensland, where she earned a Bachelor of Arts in English Language and Literature from 1987 to 1989. Additionally, she studied at the University of Queensland in 1993. Her educational background provided a strong foundation in communication and analytical skills, which have been essential in her professional roles.
Expertise in Digital Compliance and System Validation
Stephanie Cook has extensive expertise in the development and validation of GxP-regulated computerized systems. Her experience covers both bespoke and COTS systems, such as LIMS, CTMS, EDC, EDMS, eTMF, and analytical equipment. She specializes in establishing SDLC processes and validation strategies aligned with GAMP® 5 and other industry standards. Her focus on effective cross-team communication, managing user expectations, and meeting project milestones ensures the delivery of compliant and usable end products.
Skills and Values
Stephanie Cook values staff development and aims to achieve team goals of quality, competence, consistency, and efficiency. She is skilled in evaluating regulated COTS systems to establish or remediate them toward a validated state. Additionally, she possesses excellent communication and influencing skills, which are critical in her roles focusing on compliance and project management.