Senior Director, Clinical Quality Assurance (CQA)
Core
Strategic and operational Quality Assurance leadership for multiple registrational global clinical trials, ensuring GCP compliance and inspection readiness.
Role type
Senior Director, Clinical Quality Assurance (CQA)
Builds
Global clinical trials for late-stage biotechnology therapeutics (retinal vascular diseases, cystic fibrosis)
Domain
Biotechnology / Clinical Development / Regulatory Quality
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GCP compliance, risk-based oversight, audit management, CAPA leadership, inspection readiness, cross-functional stakeholder influence, clinical quality strategy, vendor management, training development
Preferred skills
Advanced degree (MS, PharmD, PhD), experience in biotech/pharma regulated environment
Technologies
GCP, ICH E6, DSUR, Module 2.6, Module 2.7
Responsibilities
Provide strategic Quality leadership and oversight for multiple clinical studies; Lead development and governance of Clinical Study Quality Plans; Manage, mentor, and develop Clinical QA staff; Define and perform risk-based GCP compliance audits of vendors/sites; Lead investigation and management of significant Clinical Study Quality Events; Provide senior Quality review on clinical documents (Protocols, IBs, Summaries); Lead GCP inspection readiness and support inspections
Seniority
Senior Director, strategic & operational leadership
