Director of Quality Assurance Inspections - Europe remote
- 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.
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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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