Senior Manager, Corporate Audit
Core
Planning, leading, and conducting independent Good Clinical Practice (GCP) audits and risk oversight activities to ensure compliance with regulations and internal policies.
Role type
Senior Manager, Corporate Audit (GCP)
Builds
Independent assessments of control design and operating effectiveness for clinical development operations.
Domain
Life Sciences / Clinical Development / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GCP audit planning and execution, risk assessment, data analytics, regulatory knowledge (ICH GCP), project management, leadership, strategic thinking, compliance gap identification
Preferred skills
GCP risk assessment experience, advanced degree in life sciences, experience with outsourcing and partnerships
Technologies
None explicitly stated
Responsibilities
Lead scheduled GCP audits and conduct risk oversight activities, analyze large data sets to identify risks and discrepancies, develop customized audit plans, communicate audit findings and recommendations to senior management, document audit work and prepare formal reports, improve audit processes and oversight approaches
Seniority
Senior Manager, hands-on leadership
