Quality Manager, Quality Assurance
Core
Fosters a culture of quality and acts as an ambassador for the QA department, leading internal and vendor audits and quality risk management.
Role type
Quality Manager (QA)
Builds
Internal and vendor audit programs, quality risk management activities, and compliance mechanisms.
Domain
Pharmaceutical clinical research (GxP, GCP, GVP)
Required skills
Audit program management, Quality Risk Assessment methodology, Vendor oversight, Regulatory compliance (EU GVP, USFDA, ICH-E6), GxP expertise
Preferred skills
GCP/GVP regulatory knowledge, Client contracted services (Quality as a Service), Audit documentation peer review
Technologies
EU GVP, USFDA CFRs, JMPA, ICH-E6
Responsibilities
Develops and maintains the internal Quality Risk Assessment methodology; Leads Quality Assurance activities in relation to procurement and vendor oversight; Coordinates and contributes to internal system and/or vendor audits; Monitors compliance within the organization to ensure early identification of risks.
Seniority
Mid-level, hands-on IC
