Are you passionate about quality and precision? Join our client's Clinical Quality Assurance team and help ensure top-tier standards every day.
Proclinical is seeking an Associate Director/Director of Clinical Quality Assurance to lead the development, implementation, and continuous improvement of clinical QA systems. In this role, you will ensure compliance with ICH-GCP, EU, and local regulatory requirements for clinical research activities. You will oversee internal and external clinical quality activities, provide strategic input into R&D processes, and prepare for regulatory inspections. This position involves building and managing a fit-for-purpose CQA function while serving as a subject matter expert and advocate for clinical quality.
Responsibilities:
- Develop, implement, and maintain a risk-based clinical quality management system aligned with regulatory requirements (e.g., ICH-GCP, EU Clinical Trials Regulation).
- Support clinical study teams in interpreting and applying GCP standards and internal SOPs.
- Lead preparation, hosting, and follow-up for regulatory agency GCP inspections and clinical quality audits.
- Conduct and manage internal and external CQA audits, including sites, vendors, CROs, and study documents/data.
- Oversee CAPA (Corrective and Preventive Action) processes, support root cause analysis, and ensure timely resolution.
- Provide GCP training for internal teams and relevant external partners.
- Advise management on GCP compliance risks, mitigation strategies, and regulatory trends.
- Collaborate across functions to promote a culture of quality in clinical trial activities.
- Act as the primary CQA contact for clinical development projects and external partners.
- Develop quality metrics dashboards for regular management review and decision-making.
- Ensure the quality, accuracy, and compliance of clinical trial data through CQA oversight of data collection, processing, and reporting.
- Participate in or lead the evaluation and selection of external clinical service providers from a CQA perspective.
Key Skills and Requirements:
- Degree in a relevant field such as Biotechnology, Life Sciences, or Engineering; advanced degree preferred.
- Strong knowledge of ICH-GCP, EU Clinical Trials Regulation, and applicable local requirements.
- Experience in Clinical Quality Assurance within the biotechnology or pharmaceutical industry.
- Proven expertise in preparing for and leading regulatory GCP inspections.
- Solid understanding of clinical trial operational processes and quality risk management.
- Ability to work effectively in a cross-functional, matrixed team environment.
- Excellent communication, leadership, and problem-solving skills with a hands-on approach.
- Familiarity with computerized systems for clinical records management and data integrity principles.
- Skilled in influencing, persuading, and providing GCP-related training.
If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@proclinical.com.
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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