Director of Quality Assurance Inspections
A large and established organisation are looking for an experienced Director of Quality Assurance Inspections. This organisation is dedicated to saving roles and this would be the perfect opportunity to be a part of this medical journey.
- 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 the company 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
- 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
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.