Senior QA Specialist
Core
Lead quality assurance and compliance efforts for clinical research programs, managing audits, investigations, and quality management systems.
Role type
Senior Quality Assurance Specialist (Clinical Research)
Builds
Quality management systems and compliance processes for clinical research
Domain
Life Sciences / Clinical Research / Pharmaceutical
Deliverable
dashboards & analysis
Required skills
GxP regulations, audit management, root cause analysis, SOP development, quality investigations, CAPA management, regulatory compliance, stakeholder liaison, mentorship
Preferred skills
ISO standards, 21 CFR knowledge, risk assessment, conflict management
Technologies
Computer software (in-house and off-the-shelf)
Responsibilities
Lead client and regulatory audits, develop and update SOPs, perform root cause analysis, generate quality reports, mentor junior staff, ensure compliance with GxP/GDP regulations
Seniority
Senior, hands-on IC
