Compliance Manager

Job Description

Conduct complex internal and external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines, and client contractual obligations.

Identify issues impacting the quality and/or integrity of clinical research programs, determine root cause of non-conformance and develops strategies to address issues.

Perform technical document review and other GxP practice activities in support of clinical development programs.

Provide audit reports to management.

Plan and deliver quality services including contracted quality assurance audits, internal site audits, laboratory and file audits for clients and projects.

Lead process/quality improvement initiatives.

Mentor junior staff.

Develop tools and other materials for tracking of compliance management activities and analyze trends.

Upon request, support regulatory inspections and/or client audit hosting.