This is to lead the Clinical Quality for an organisation with a truly exciting number of ongoing clinical trials, with more planned as they springboard off their global success and begin to make their mark on the US immuno-oncology market. With an established global team of world-renowned industry leaders, they're offering the chance to get in early before things get even bigger!
- Meet the ongoing needs of the quality assurance department by maintaining CQA compliance for ongoing and planned clinical trials.
- Work with clinical operations and regulatory affairs to review IND and NDA submission documents.
- Lead investigations and write CAPAs on GCP issues as they arise.
- Responsible for ensuring submission data and documentation meets GCP guidelines.
- Perform and/or support audits of clinical sites, CROs and other clinical vendors.
- Ensure proper maintenance of the Quality systems.
- 10 cumulative years of related quality or clinical experience within pharmaceutical companies or Contract Research Organizations (CROs).
- Education and experience in an FDA-regulated environment.
- Bachelor's degree
- Ability to plan and organize work in an efficient manner and work well under time constraints.
- Demonstrates effectiveness in maintaining CQA control systems for compliance with FDA regulations.
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.
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