Senior Manager, Clinical Quality Assurance - Americas
Core
Drive quality excellence and ensure compliance for clinical research activities and trials across designated countries in the Americas to achieve first-pass market authorization.
Role type
Senior Manager, Clinical Quality Assurance
Builds
Quality systems, audit strategies, and regulatory readiness for clinical development pipelines.
Domain
Biopharmaceutical / Clinical Research / Regulatory Affairs
Required skills
Quality assurance, regulatory compliance, risk management, auditing, change management, data integrity, leadership, strategic planning
Preferred skills
Medical science background, cross-functional collaboration, inspection readiness, supplier qualification
Technologies
Quality management systems, regulatory databases, audit tools
Responsibilities
Oversee quality and compliance in a regulated environment; lead risk identification and mitigation strategies; conduct audits to assess regulatory compliance; support supplier visits and vendor qualifications; provide inspection-readiness support for Health Authority inspections; mentor AREA Managers and Associates.
Seniority
Senior, hands-on IC with leadership responsibilities
