Senior QA Specialist
Core
Lead quality assurance efforts to maintain and enhance the quality and compliance of clinical research programs, managing audits, investigations, and quality improvement initiatives.
Role type
Senior Quality Assurance Specialist (Clinical Research)
Builds
Quality management systems and processes for clinical research programs
Domain
Pharmaceutical/Clinical Research
Required skills
GxP regulations expertise, audit leadership, root cause analysis, CAPA management, SOP development, regulatory compliance, quality investigations, risk assessment, data reporting
Preferred skills
ISO standards knowledge, vendor audit experience, conflict management, project management
Technologies
GxP audit tools, quality management software, reporting tools
Responsibilities
Lead client, regulatory, and internal audits; Develop and update SOPs; Perform root cause analysis and resolve quality issues; Generate tracking and analysis reports; Mentor quality staff; Ensure compliance with GxP/GDP regulations
Seniority
Senior, hands-on IC
