Manager, Good Clinical Practices
Core
Leading compliance activities, managing external audits, and driving quality improvement projects for clinical practices.
Role type
Manager, Quality & Regulatory Affairs (GCP)
Builds
Compliance programs and audit readiness for clinical studies and facilities
Domain
Medical Devices / Clinical Research / Regulatory Affairs
Deliverable
client delivery
Required skills
GCP/GLP regulatory knowledge, audit management, CAPA coordination, SOP development, quality management systems implementation, project management, operational decision-making
Preferred skills
ISO 14155, ICH E6, Medical Device EU regulations, FDA regulatory requirements, Declaration of Helsinki knowledge, validated GCP audit track record
Technologies
GxP regulations, Standard Operating Procedures (SOPs)
Responsibilities
Manage individual projects to achieve objectives and improve operational efficiency; oversee day-to-day operations and resource management; implement quality management systems and regulatory standards; perform and support inspections/audits of processes, documents, facilities, and suppliers; coordinate Corrective and Preventive Action (CAPA) processes; report quality issues and deviations; lead implementation of new regulations and international standards.
Seniority
Manager, hands-on leadership