Clinical Quality Operations Manager
Core
Execute operational quality management and inspection readiness activities across assigned clinical programs, embedding quality-by-design principles and risk-based quality plans.
Role type
Senior Clinical Quality Operations Manager
Builds
Clinical trials and study-specific quality plans
Domain
Biopharmaceuticals / Clinical Research & Development
Required skills
GCP compliance, risk-based quality planning, CAPA management, vendor oversight, inspection readiness, cross-functional collaboration, data analysis for process improvement
Preferred skills
Lean Six Sigma, PMP, knowledge of ICH E6(R3)
Technologies
Risk Assessment and Categorization Tools (RACTs), digital data management tools
Responsibilities
Ensure consistent execution of quality-by-design principles in clinical trials; Review and validate quality plans and risk assessments; Partner with CQA on inspection preparation and management; Lead CAPA implementation for internal and external audits; Monitor vendor and CRO performance against quality expectations; Standardize clinical quality operations procedures and templates.
Seniority
Senior, hands-on IC