Senior Manager, Clinical Quality Assurance
Core
Lead global clinical quality investigations, audits, and regulatory compliance for a clinical-stage vaccine company.
Role type
Senior Manager, Clinical Quality Assurance
Builds
Compliant clinical trial operations and high-quality healthcare solutions
Domain
Biopharmaceuticals / Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global investigation leadership, CAPA management, Root Cause Analysis, audit planning and execution, regulatory compliance (FDA/ICH), QMS system proficiency, risk-based auditing
Preferred skills
GCP QA Certification, Veeva QMS experience, experience across all clinical development phases
Technologies
Veeva, eQMS
Responsibilities
Lead global investigations and support CAPA preparation; Manage Quality Issues and serious breach investigations; Review and approve RCA and CAPA plans; Plan and conduct risk-based audits of clinical sites and CROs; Support regulatory agency inspection readiness; Evaluate policies for compliance and recommend process improvements
Seniority
Senior Manager, hands-on leadership
