Senior Director, Clinical Quality Assurance (CQA)
Core
Provide strategic and operational Quality Assurance leadership for multiple registrational, global clinical trials to ensure compliance with Good Clinical Practice (GCP) and international regulatory requirements.
Role type
Senior Director, Clinical Quality Assurance (CQA)
Builds
Global clinical trials for late-stage biotechnology products (ophthalmology and cystic fibrosis)
Domain
Biotechnology / Clinical Development / Regulatory Quality
Required skills
GCP compliance, risk-based oversight, audit management, CAPA management, inspection readiness, cross-functional stakeholder leadership, clinical quality strategy, vendor management, training development
Preferred skills
Advanced degree (MS, PharmD, PhD), Ophthalmology experience, experience in small company environments
Technologies
GCP, ICH E6, Module 2.6, Module 2.7
Responsibilities
Lead development and governance of Clinical Study Quality Plans; manage and mentor Clinical QA staff; perform risk-based GCP compliance audits of vendors/sites; oversee investigation and management of significant Clinical Study Quality Events; lead GCP inspection readiness and support inspections; partner with cross-functional teams to embed quality into study design.
Seniority
Senior Director, strategic & operational leadership
