| by Amy Carabase

Governance, Risk and Compliance Technology Implementation

Queen Consulting Group Case Study

Governance, Risk and Compliance Technology Implementation

Queen partners with many different types of life sciences companies, including Pharmaceutical, Medical Device, and Biotech companies to recruit the top talent available in the market, with the niche skills you need for your projects.


CLIENT OVERVIEW

Our client is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of rare, life-threatening genetic diseases, and has several ongoing clinical and research programs.

CHALLENGE

This organization was looking for Program Management support in the area of IT Governance, Risk and Compliance (GRC) to augment their technology team supporting the Chief Medical Officer, Chief Quality and Regulatory Officer, and Chief Patient Officer.

They had several initiatives planned, including improving Access Reviews, Inspection Readiness, and enhancing a ServiceNow module to support GRC activities. They needed a consultant with expertise in Governance, Risk and Compliance in a GxP environment, experience with SOX and other controls, as well as senior Program Management experience.

APPROACH

Queen provided a consultant that had extensive experience working with IT teams in pharmaceutical organizations as well as a background in Chemistry. This individual had experience managing applications for multiple areas such as Medical Affairs, Technical Operations, Legal, Corporate Communications, Global Quality, Corporate Compliance, Regulatory Affairs, and IT. They oversaw delivery teams and managed a variety of projects including GRC.

The QCG consultant worked with IT and Audit teams to gain an understanding of the gaps and issues that they could address with the Audit module of ServiceNow. They worked with the IT team to understand how the technology worked and how it could be used to improve their workflow. Working across cross-functional teams, they needed to plan the implementation and fit it into the ServiceNow release cycle.

Our consultant also worked on projects to automate Access Control processes and optimize Access Reviews, which traditionally involved very manual processes. They performed landscape systems analysis to see what technology was available on the market that could help.


IMPACT

Our consultant was able to jump in quickly and come up to speed in learning the environment and build key relationships to drive these projects forward. They were able to manage teams to scope out technology projects to simplify cross-functional integration, communication, and processes. The systems embed risk-informed decisions into daily work and connect the business, security, and IT with GRC.