PRA Health Sciences

Director of Quality Assurance Inspections - Europe remote

France (FR) Europe - remote
01 Apr 2021
01 May 2021
Full Time
Contract Type
Experience Level
Senior Management

To save lives, or enable people to live better lives, is no small thing. And we know you can’t do it by yourself. That’s why PRA enjoys a people-first culture of value, respect and support. We feel proud to have fostered a supportive working environment, where flexibility and collaboration reign supreme. And it’s this collaborative culture that drives the development of life-saving treatments for patients around the world.

If you're ready to be a part of something inspiring join us and Discover Your PRA.

What will you be doing?

As a  Director of Quality Assurance and a subject matter expert you will lead PRA’s Inspection Readiness and Management Team for the preparation, conduct and response to GCP Regulatory Inspections.  

Key Responsibilities include but are not limited to:

  • Lead the ongoing development, management, and implementation of written processes for the effective management of PRA’s Inspection Readiness programme and the organisation of Regulatory Inspections. 
  • Lead the reporting of trends and metrics from all inspection readiness and management activities across PRA to aide effective process improvement and risk identification and mitigation.
  • Establish strong working relationships with functional leaders and QA colleagues
  • Actively participate in the hiring of new QA staff and ensure new QA employees are trained and qualified to perform their tasks
  • Define strategic and functional direction, as well as team/ individual goals 
  • Define future work methodologies to better meet customer needs
  • Broadly and globally interpret regulations and guidance documents governing GxP and serve as an expert and consultant to PRA staff and client representatives 
  • Provide guidance and oversight in managing and responding to compliance questions and resolve compliance related issues.
  • Participate in and/or lead, as assigned, GxP related projects initiated by internal stakeholders

Location: This role can be office-based or remote in Europe or US. Candidates should be eligible to work in the location they apply to. 

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