Associate Director, QA - Cambridgeshire
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As Associate Director, you will be responsible for the performance of the QA units across three UK sites located in Cambridgeshire and the Midlands, and as such regular travel between sites is required. You will be a strong operational leader with significant experience of working in a QA environment, responsible for resource planning and organisation of workload at a senior level. You will have strong regulatory compliance experience, including GLP and GCLP, within the life science industry. We are looking for a highly credible individual who has great managerial skills, is passionate about developing people and enjoys leading the team to success. In this role you will be an opinion leader and have a voice in the regulatory arena to provide expert guidance and help shape future policy. Ideally you will be a member of the Research Quality Association or another recognised quality body.
As Associate Director, QA your main responsibilities will be:
- Maintaining an up to date awareness of GLP and GCP (GCLP) and awareness of changes in Regulatory Compliance requirements or expectations and communicating these changes to management and staff.
- In association with the Director QA and Associate Director EMEA, establishing a harmonised CRS EMEA QA program that provides consistent, effective and efficient use of QA resource whilst still meeting regulatory requirements.
- Assisting in the development, maintenance and delivery of the QA strategic plans.
- Contributing to the promotion of the profile of the Company by attending external regulatory meetings and seminars and delivering presentations or training sessions where appropriate.
- Ensuring areas of potential compliance weakness are identified and proactively addressed.
- Ensuring appropriate collation of metrics and trend information of findings and their effective reporting to management in accordance with the Quality Council structure.
- Ensuring audit and inspection programs are maintained across the UK CRS sites.
- Maintaining budgetary control for the UK CRS sites.
- Providing direct line management for the QA Managers across the UK
The skills and experience we’re looking for are:
- Significant experience of auditing GxP studies.
- Experience of managing teams of people
- Significant experience of working in a business/QA environment responsible for resource planning and organisation of workload at a senior level
- Significant experience of working directly with customers and representatives from regulatory bodies
- Member of a Quality Assurance professional body
- Significant experience of undertaking root cause analysis and risk assessment
- Highly effective communicator at all levels of the business, with high levels of emotional intelligence when handling potentially challenging feedback
- Solution orientated with ability to think outside of-the-box
- Degree in a scientific discipline or equivalent Quality Management qualification