Quality Manager, Quality Assurance
Core
Strengthen quality standards and ensure regulatory compliance across a global clinical research environment by developing risk-based audit strategies and overseeing internal and vendor audits.
Role type
Quality Manager (Clinical Research & Pharmacovigilance)
Builds
Internal and vendor audit programs, risk-based audit strategies, and compliance monitoring mechanisms.
Domain
Clinical research, pharmacovigilance, and regulatory compliance (GxP).
Required skills
GCP/GVP auditing, risk-based audit planning, regulatory compliance monitoring, vendor oversight, audit documentation management, GxP consulting.
Preferred skills
Experience with rare diseases and oncology clinical research programs.
Technologies
ICH-E6, EU GVP, US FDA CFRs, PMDA requirements.
Responsibilities
Develop and maintain internal Quality Risk Assessment methodology and Audit Universe; Lead QA activities related to procurement and vendor oversight; Establish and manage mechanisms for ongoing compliance monitoring; Partner with operational teams to implement risk-based audit strategies; Coordinate internal system and vendor audits; Manage pre-audit and post-audit activities; Conduct audits within areas of GxP expertise; Support client-contracted QA services; Provide GxP QA consulting services; Monitor organizational compliance and assess risks; Promote a strong quality culture.
Seniority
Mid-level, hands-on IC