Lead the charge in safeguarding clinical excellence-step into a pivotal Senior Director QA role where your expertise ensures the highest standards in pharmaceutical innovation.
Proclinical is seeking an Associate Director of Clinical Quality Assurance to oversee GCP activities, lead audits and inspection management, and ensure the high-quality execution of clinical trials. This role involves collaborating with internal and external stakeholders, providing GCP QA support, and contributing to the continuous improvement of clinical development processes.
Responsibilities:
- Represent Clinical Quality Assurance (CQA) in cross-functional team meetings.
- Support the training and development of CQA colleagues.
- Provide proactive GCP QA support to ensure patient safety, data integrity, and operational excellence.
- Conduct various audits, including Clinical Investigator Site Audits, GCP Document Audits, Clinical Study Reports, Trial Master Files, internal Process Audits, and Vendor-System audits.
- Act as the CQA Lead for clinical studies, managing audit plans and reports.
- Facilitate quality improvement by communicating audit results, CAPAs, and providing GCP guidance to clinical teams.
- Manage health authority inspection preparation and provide leadership during inspections.
- Review and provide input on clinical documentation such as protocols, study reports, IBs, and ICFs.
- Compile and analyze audit metrics to identify trends and communicate findings to business groups.
- Conduct GCP training sessions for internal teams.
Key Skills and Requirements:
- Bachelor's degree in a relevant discipline.
- Experience in Clinical Quality Assurance within the pharmaceutical industry.
- Knowledge of health authority inspection management.
- Ability to develop SOPs and training materials.
- Proficiency in conducting routine, complex, and for-cause GCP audits.
- Strong interpersonal and professional communication skills.
- Effective time management and ability to handle competing priorities.
- Familiarity with US, EU, and international regulatory standards for clinical trials.
- Attention to detail, analytical thinking, and strong report writing skills.
- Ability to navigate challenging situations diplomatically and collaboratively.
- Proficiency in English (spoken and written).
- Willingness to travel approximately 25%.
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.
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