Clinical Development Quality Manager (GCP)

Proclinical Staffing; Egham; On-site; GBP 45,000 - 75,000; Full time

Job summary

This innovative firm is seeking a Clinical Development Quality Manager to enhance compliance in clinical studies. You will lead the development of a quality management system, ensuring adherence to Good Clinical Practice (GCP) and regulatory guidelines. Your role will involve coordinating audits, preparing regulatory submissions, and providing training across all phases of clinical drug development. Join a forward-thinking organization dedicated to making a tangible difference in the life sciences sector, where your contributions will play a crucial role in advancing clinical research and ensuring the highest quality standards.

Qualifications

• Degree in life sciences, biotechnology, pharmacy, or equivalent required.
• Experience in GCP QA and knowledge of GMP essential.

Responsibilities

• Develop and maintain a quality management system for clinical development.
• Coordinate audits of clinical sites and manage CAPA systems.

Skills

GCP QA

Quality Management System

Problem-solving

Effective Communication

Education

Degree in Life Sciences

Degree in Biotechnology

Degree in Pharmacy

Degree in Chemistry

Job description

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 [e-mail].

Apply Now:

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