Associate Director, Clinical Study Quality Lead (Hybrid)
Vertex Pharmaceuticals
Associate Director role overseeing clinical trial quality assurance and GCP compliance across assigned disease areas. The position involves developing audit and inspection strategies, managing quality risks, investigating compliance issues, and serving as a technical expert to clinical operations teams.
Responsibilities
- Provide strategic GCP quality compliance oversight of assigned studies to ensure regulatory adherence and participant safety
- Develop and execute risk-based audit and inspection preparedness plans for programs and studies
- Oversee quality event investigations and approve corrective action plans with effectiveness verification
- Partner with clinical teams to identify quality risks and implement proactive mitigation strategies
- Mentor junior clinical study quality leads and may assume people management responsibilities
Requirements
- Bachelor's degree in scientific or allied health field plus 8+ years relevant experience
- Deep knowledge of ICH-GCP guidelines and global clinical development regulations
- Experience across multiple clinical trial phases for drugs and biologics
- Proficiency in event management, root cause analysis, and CAPA development
- Strong written and verbal communication skills with internal and external stakeholders
- Proficient in Microsoft Office and data analysis tools (Excel, Smartsheet, Visio)
Vacancy posted 3 days ago
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