Principal Quality Compliance and Policy Leader
Core
Strategic advisor for Early Clinical Development (ECD) study teams, championing proactive quality culture and translating global regulatory requirements into robust clinical compliance strategies.
Role type
Principal Clinical Quality Compliance and Policy Lead
Builds
Early-stage clinical trial pipeline compliance and quality management systems
Domain
Pharmaceutical drug development / Clinical Quality Assurance
Required skills
GCP/ICH guidelines expertise, global health authority regulations knowledge, strategic problem-solving, matrix leadership, stakeholder management, risk-mitigation frameworks, QMS oversight, inspection readiness, KQIs/metrics establishment, team leadership
Preferred skills
Advanced degree (Master's/PhD/JD), Early Clinical Development (Phase 0–IIa/b) experience, Health Authority inspection hosting, QMS architecture development, RBQM platforms
Technologies
QMS, RBQM platforms
Responsibilities
Drive strategic partnerships across ECD and global stakeholders; Provide strategic quality direction and GCP compliance expertise; Lead global initiatives and compliance policy development; Oversee QMS activities including deviation management and CAPA evaluations; Direct Health Authority inspection readiness and SOP optimizations; Establish KQIs and compliance metrics; Champion quality culture through training; Manage and lead a team through hiring and performance development
Seniority
Principal, strategy & mentorship