Sr. Director, Clinical QA
Core
Develops and leads multi-year strategy and operational plans for Clinical QA, ensuring GCP compliance and quality oversight across the clinical development portfolio.
Role type
Sr. Director, Clinical Quality Assurance (Strategy & Operations)
Builds
Clinical Quality Management System (QMS), audit strategies, inspection readiness plans, and organizational capabilities for clinical development.
Domain
Biopharmaceuticals / Clinical Development / Regulatory Compliance
Required skills
GCP compliance, Clinical QA strategy, Regulatory inspection readiness, Quality risk management, Vendor/CRO oversight, Budgeting, Talent development, Cross-functional leadership
Preferred skills
Thought leadership, Strategic planning, Global regulatory environment analysis
Technologies
Clinical QMS, GCP audit tools, Risk management frameworks
Responsibilities
Develop and lead multi-year strategy for Clinical QA; Provide strategic leadership for GCP quality and compliance; Lead regulatory inspection readiness and oversight; Direct development and governance of the clinical QMS; Establish risk-based audit and compliance strategies; Lead and mentor Clinical QA teams.
Seniority
Senior, hands-on IC with strategic leadership
