Senior Manager/Associate Director, Quality Assurance, GCP
Core
Senior Manager/Associate Director leading Quality Assurance for early-stage (pre-phase 3) clinical development programs, ensuring GCP/GLP compliance and inspection readiness.
Role type
Senior Manager/Associate Director, Quality Assurance (GCP/GLP)
Builds
Quality assurance frameworks, audit plans, and compliance strategies for early-phase clinical trials.
Domain
Biopharmaceuticals / Clinical Development / Regulatory Compliance
Required skills
GCP regulations, GLP regulations, audit management, CAPA development, risk assessment, regulatory inspection preparation, project management, stakeholder communication
Preferred skills
Experience with FDA/EMA/MHRA inspectorates, GLP/GCP compliance interpretation, root cause analysis
Technologies
GCP, GLP, CAPA, Risk Assessment Tools
Responsibilities
Develop and maintain Quality Plans for early phase clinical programs; oversee Critical to Quality Factors and Quality Tolerance Limits; support GLP audit program activities; provide GCP/GLP compliance consultation and training; assist with preparation for regulatory inspections; escalate critical quality issues to management.
Seniority
Senior Manager/Associate Director, strategic oversight with hands-on execution