This commercial stage pharmaceutical organisation focusses on developing and delivering innovative new treatments to help improve the lives of patients with rare or orphan diseases. This organisation is committed to building a diversified portfolio of commercially attractive, best in class, proprietary new drugs to address some of these rare and debilitating illnesses. The organisation's leadership team boasts a wealth of experience in identifying, commercialising and delivering new treatments across global markets and its this success that is driving the organisation's expansion at the business Corporate Offices here in Dublin and the need for a Clinical Quality Manager to oversee GCP compliance of the organisations clinical trial program.
- The Clinical QA manager is responsible for coordination, and control of the quality activities related to clinical studies conducted by the organisation.
- The Clinical QA manager is responsible for planning, leading and executing audit activities for the audit program, and ensuring adherence to agency regulations, GCP, Industry Guidelines, local regulations, along with the organisations own policies and procedures for the conduct of clinical trials.
- This includes for evaluation of risk, implementation of procedures and facilitation of regulatory inspections.
- The role involves working closely with Clinical Operations and other functional areas/development teams, to help ensure active participation and GCP compliance.
- 3rd level qualification in a scientific or technical discipline.
- A minimum of 5 years' experience in the international pharmaceutical industry with responsibility for Quality leadership in R&D related activities.
- Lead Quality Auditor.
- Thorough understanding of all regulatory requirements related to GCP with previous experience of FDA/EMA pre-approval inspection.
To learn more about this role apply online or contact Shane Browne on + 353 1 6321865 for a confidential discussion.