Director, Operational Quality
Core
Design, implement, and continuously improve a global Quality Framework across Operations to support scalable, high-quality service delivery for biotech and pharmaceutical clients.
Role type
Director, Operational Quality
Builds
Global quality governance, risk-based quality management systems, and operational oversight for clinical trial delivery.
Domain
Biotechnology / Pharmaceutical / Clinical Research / CRO
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Operational quality leadership, risk-based quality management, ICH GCP guidelines, global clinical trial delivery, quality metrics and KRIs, strategic thinking, cross-functional oversight, client-facing communication, regulatory compliance, complex problem solving.
Preferred skills
Project Management, Clinical Operations, Biometrics.
Responsibilities
Establish practical governance and meaningful quality metrics; define escalation pathways for risk identification; partner with functional leaders (Project Management, Study Start-Up, Biometrics, Clinical Operations, Site Solutions, Safety, Medical Monitoring, Medical Writing); drive accountability and consistent delivery outcomes; support business development discussions.
Seniority
Director, strategic leadership & cross-functional oversight
