Director, Clinical Quality Assurance
Core
Developing and implementing global strategic quality oversight for Therapeutic Areas within clinical development programs to ensure data integrity, regulatory compliance, and successful drug/device development submissions.
Role type
Director, Clinical Quality Assurance
Builds
Global quality strategies and high-performing QA teams for clinical development programs
Domain
Biopharmaceuticals / Clinical Research / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic planning, GxP compliance, GCP regulations, Quality Risk Management, Change Management, CAPA, Team leadership, Cross-functional collaboration, Regulatory inspection readiness, Process improvement, Vendor QA management
Preferred skills
Advanced business acumen, Negotiation, Cultural awareness, Coaching, International travel
Technologies
GxP systems, Quality Management Systems, Clinical Development Platforms
Responsibilities
Deliver innovative quality strategies and solutions through collaboration with RDQA, R&D, and external providers; Build a strategic, high-performing team within Therapeutic Areas; Engage across QA GxPs and deliver mitigation strategies to critical business partner networks; Drive development and implementation of necessary GCP systems; Provide leadership and collaboration in health authority inspections; Promote continuous education on quality assurance and GCP guidelines.
Seniority
Director, strategic leadership with direct reports