Diane Gates

Diane is an accomplished Quality professional with over 20 years of extensive experience in the pharmaceutical industry. She holds both a Master’s and Bachelor’s degree in Chemical Engineering and has expertly transitioned between pivotal roles in validation and quality assurance, contributing to both established pharmaceutical firms and innovative start-ups.

Throughout her career, Diane has provided exceptional Quality oversight for products such as autologous immunotherapies, combination products, and parenterals, and has developed robust validation programs tailored to those specific needs. Following her most recent role leading the Quality unit of a national organization, she founded CenPharma, LLC, where she offers invaluable expertise in Quality, Inspection Readiness, and Validation.

Diane possesses in-depth knowledge of Quality Assurance, Quality Control, Compliance Remediation, Inspection Readiness, as well as Data Integrity, Computer System Validation, Cleaning and Process Validation. Her unique blend of experience enables her to effectively apply regulations and best practices across various sectors.

Beyond her professional achievements, Diane is passionate about mentoring emerging leaders and entrepreneurs from all industries. She is dedicated to sharing her extensive knowledge and fostering resilience, strategic thinking, and innovation in the next generation. Through her guidance, Diane empowers aspiring leaders to navigate challenges confidently and drive meaningful change in their respective fields.