Stephen J Cook

Sr. Director – Governance & Operational Excellence, Global Digital & Tech, GSK


Stephen believes that we need to move beyond “validating” to delivering technology that are sound, reliable and “fit for purpose.” This transcends just GxP thinking. Breaking down compliance silos in organizations is both more efficient and more effective, considering the overlap in requirements from multiple regulatory arenas (GxP, financial, security, and privacy). IT organizations need to partner with their business functions and quality to identify innovative solutions. The best work happens when these stakeholders can use the procedures as “guardrails” and propose creative, pragmatic solutions. Technology is changing ever more rapidly, and dogmatic thinkers will go the way of the dinosaurs. Stephen has provided innovative integrated compliance solutions, executed countless CSA protocols, and delivered 100’s of lean policies and procedures at many companies in his career. Stephen now leads the GSK GRC – Governance and Operational Excellence teams with responsibilities for process improvements, ITMS documentation, training, demand and resource management, independent business monitoring, risk controls assurance, SOX testing, disaster recovery, ABAC, regulatory intelligence, and software asset management. Stephen brings 25+ years of experience in quality manufacturing, facilities, and equipment design, build and testing, and software validation and integrated compliance. He has previously held positions with Compliance Group, Baxter Healthcare and Fresenius Kabi USA. He is also excited to be a new member of the FICSA team working with FDA and industry to simplify software validation approaches.