Ken Strode

Ken Strode has extensive work experience in the field of quality assurance and regulatory compliance in the pharmaceutical industry. Ken has held various leadership roles in companies such as the Pancreatic Cancer Action Network, Seagen, Cognizant, FHI 360, Strode Consulting, GSK, Stiefel (a GSK company), Amgen, and Bristol-Myers Squibb.

In their most recent role as Senior Director, Quality Assurance Lead at Pancreatic Cancer Action Network, Ken is responsible for overseeing GCP, GVP, and IMP GMP Quality Assurance for an adaptive design platform trial company.

Prior to that, they served as the Director of Good Clinical Practice and Pharmacovigilance Quality Assurance at Seagen, where they provided direction and oversight for GCP QA, computer systems validation, Clinical Trials Supplies, Training Program, and Pharmacovigilance Quality Systems.

Ken also held significant leadership positions at Cognizant as the Life Sciences Business Unit Compliance Officer and Senior Regulatory Compliance Officer, at FHI 360 as the Director of Regulatory Affairs and Compliance, and at Stiefel (a GSK company) as the Senior Director of R&D QA and Compliance, Director of Global GCP Quality Assurance, and Director of GCP/GLP and Pharmacovigilance Compliance, North America.

Before that, they worked as a Senior Consultant at Strode Consulting, where they assisted clients in developing and improving their quality systems and processes.

Ken began their career at Amgen, where they held the position of Senior Manager, Compliance in Global Research and Development Compliance and gained experience in managing audit staff, audit scheduling, and the GCP training program.

Ken also worked at Bristol-Myers Squibb as a Manager of Regulatory Compliance.

Throughout their career, Ken has demonstrated expertise in areas such as GCP, GLP, GMP, 21 CFR Part 11, Data Integrity, Pharmacovigilance, and Risk Management. Ken has led the development and implementation of regulatory compliance oversight programs, managed audit staff, and provided direction for various quality and regulatory initiatives.

Ken Strode holds a Bachelor's Degree in Computer Science from Southern Connecticut State University. Ken has also obtained a variety of certifications from Coursera, covering subjects such as philosophy, risk management, astronomy, nutrition, and psychology. The certifications were obtained between 2013 and 2015.