Executive Director of Clinical Quality
Confidential
Executive Director of Clinical Quality
About the Company
Pharmaceutical company focused on clinical quality, auditing, and regulatory compliance.
Industry
Pharmaceuticals
Type
Privately Held
About the Role
The Company is seeking an Executive Director of Clinical Quality to lead its Clinical Quality Assurance team. The successful candidate will be responsible for ensuring adherence to Good Clinical Practices (GCP) and regulatory standards across clinical programs. This includes overseeing auditing processes, collaborating with cross-functional teams to address deviations, and implementing corrective actions. The role also involves developing and executing comprehensive audit plans, providing strategic guidance and training for clinical investigator meetings, and maintaining tracking systems for audit activities. Applicants must have a Bachelor’s degree in nursing, health science, or a related field, with a minimum of 15 years' of experience in clinical auditing and compliance, including executive-level expertise. Proficiency in GCP auditing, comprehensive knowledge of US and ICH GCP regulations, and experience with clinical safety and trial management systems are essential. The role requires exceptional interpersonal, communication, and organizational skills, as well as the ability to manage complex projects and handle competing timelines. The Executive Director will be expected to travel 40-60% of the time for audits and collaborative engagements.
Functions
- Operations
Vacancy posted 2 days ago
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