Quality Assurance Manager - Government Operations
Core
Oversee quality management activities, ensure compliance with regulations in a regulated clinical research environment, and lead audits and inspections.
Role type
Senior Quality Assurance Manager
Builds
Compliance and quality systems for government operations
Domain
Clinical research / Government operations
Deliverable
dashboards & analysis
Required skills
Quality management systems, regulatory compliance, auditing, CAPA, document control, SOP governance, stakeholder management
Preferred skills
CQA, RAC, RQAP, Six Sigma
Technologies
Microsoft Office
Responsibilities
Manage internal auditing program, document control, and CAPA processes; Supervise QA department members; Review and approve audit reports; Develop internal audit schedule; Lead client audits and regulatory inspections; Conduct internal and vendor audits; Draft and update QA policies and procedures; Review corporate SOPs; Contribute to process improvement initiatives; Prepare quality management reports; Deliver quality and compliance training; Communicate quality concerns and findings to management.
Seniority
Senior, management level