Senior Manager, Clinical Quality Assurance
Core
Leading GCP quality activities and risk management to ensure compliance with global regulations and deliver submission-ready data for drug development programs.
Role type
Senior Manager, Clinical Quality Assurance
Builds
Submission-ready quality data for market authorization
Domain
Pharmaceutical industry, Clinical Development, GCP Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic planning, Cross-functional execution, Risk and issue management, Audit program design, Regulatory interpretation, Team leadership, Project management, Global regulatory knowledge, Problem solving
Preferred skills
Oncology-specific experience, GCP QA auditing experience
Technologies
GCP, GXP, Clinical Development Systems
Responsibilities
Develop and manage project timelines for the RDQA Comprehensive Quality Strategy plan, Design and execute internal and external compliance audits, Interpret and apply governmental regulations to study protocols, Prioritize activities to meet study/program objectives, Identify and mitigate clinical quality risks, Lead the effort to articulate an integrated cross-functional quality strategy plan, Serve as the primary program quality liaison during health authority inspections
Seniority
Senior, hands-on IC with leadership responsibilities