We are on the hunt for bold, innovative thinkers who are ready to help push the boundaries of science and make a tangible difference in the world.
Proclinical is seeking a Clinical Development Quality Manager to join our client's team in Surrey. In this role, you will focus on ensuring compliance and mitigating risks related to clinical studies, adhering to Good Clinical Practice (GCP) and other relevant guidelines. You will lead internal audits and support regulatory inspections, maintaining a robust quality system.
Responsibilities:
- Develop and maintain a quality management system for clinical development activities.
- Coordinate audits of clinical sites, CROs, manufacturers, suppliers, and laboratories.
- Drive the creation and implementation of SOPs to support clinical trial processes.
- Maintain an annual audit schedule and manage CAPA systems for audit findings.
- Prepare and review documentation for regulatory submissions.
- Provide training across all phases of clinical drug development.
- Collaborate with project teams to ensure compliance with ICH guidance and regulations.
- Report quality updates to senior management and stay informed on regulatory trends.
Key Skills and Requirements:
- Degree in life sciences, biotechnology, pharmacy, chemistry, or equivalent.
- Experience in GCP QA and knowledge of GMP.
- Proven track record in building and maintaining a Quality Management System.
- Strong problem-solving skills and ability to work in regulated environments.
- Effective communication and influence management skills.
- Demonstrated integrity, ethical standards, and collaborative teamwork abilities.
If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@proclinical.com.
Apply Now:
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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