Director of Quality Assurance - Inspections

PRA Health Sciences - Europe - USA - 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. You are A quality focused self-starter with the ambition to share your knowledge! Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have: An undergraduate degree or its international equivalent in health sciences, auditing etc. from an accredited institution More than 12 years industry experience with at least 8 years of Clinical QA and managerial experience Extensive experience in regulatory inspection readiness and management activities A thorough understanding of EU and/or US clinical trials regulations Understanding of all aspects of clinical research, including protocol development, CRF design, clinical trial management (including laboratory methodologies and clinical examinations), data management, statistical analysis, clinical study reports, and regulatory submissions preferred Read, write and speak fluent English Global experience in a CRO Quality Assurance environment preferred To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better. For more information please visit our website: www.prahs.com... - Permanent - Full-time

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