Job Description

4272 Posted: 30/08/2023

• Competitive
• London, United Kingdom
• Permanent

Quality Assurance Expert
Position Overview:
We are seeking a highly skilled and experienced Quality Assurance Expert with a strong background in Good Clinical Practice (GCP) to join our dynamic team. The ideal candidate will play a crucial role in ensuring the highest standards of quality and compliance in our clinical trials and research activities whilst acting as advisor to the Clinical Development teams on all quality related GCP activities. If you have a deep understanding of GCP guidelines, a meticulous attention to detail, and a commitment to excellence, we invite you to apply for this exciting opportunity.

Key Responsibilities:
GCP Compliance: Ensure that all clinical trials and research activities conducted by the organization adhere to GCP guidelines and other relevant regulations.
Quality Oversight: Conduct regular reviews of clinical trial documentation, protocols, and reports to verify compliance with GCP standards and internal quality procedures.
Audits and Inspections: Prepare for and participate in internal and external audits and inspections related to clinical trials, addressing findings and implementing corrective actions as needed.
SOP Development: Collaborate with cross-functional teams to develop and maintain Standard Operating Procedures (SOPs) related to clinical trial quality and compliance.
Risk Assessment: Identify and assess potential risks in clinical trial activities, and work with teams to develop risk mitigation strategies.
Training and Education: Provide training and guidance to clinical trial personnel on GCP principles, regulations, and best practices.
Documentation Management: Oversee the management and maintenance of clinical trial documentation, including study master files and essential documents.
Continuous Improvement: Proactively identify opportunities for process improvement within the quality assurance function and contribute to the development of best practices.
Reporting: Generate regular reports on the status of quality and compliance in clinical trials for senior management.
Collaboration: Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, and Data Management, to ensure a coordinated approach to quality assurance in clinical trials.

Qualifications:

• Bachelor\'s degree in a relevant scientific discipline; advanced degree preferred.
• Several years of experience in Quality Assurance within the biotechnology or pharmaceutical industry, with a focus on clinical practice.
• In-depth knowledge of Good Clinical Practice (GCP) guidelines and relevant regulations (FDA, EMA, ICH, etc.).
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Proven experience in conducting audits and inspections.
• Detail-oriented with a commitment to accuracy and compliance.
• Ability to work independently and as part of a team.

How to Apply:
If you are a dedicated Quality Assurance Expert with a passion for ensuring the highest standards of quality in clinical trials and research, we encourage you to apply. Please submit your CV highlighting your relevant experience, and any relevant certifications.

Warman O\'Brien