Senior Manager, GCP Quality Assurance

Job Summary

To support clinical development programs, the full-time Senior Manager, GCP Quality Assurance will manage audits, oversee quality issues, and ensure compliance with GCP regulations while collaborating with various internal and external stakeholders in a remote working environment.

Key Responsibilities

• Provide guidance on GCP, GLP, and GVP requirements to clinical development teams, identifying compliance risks and supporting mitigation strategies
• Collaborate with internal and external partners to ensure consistent compliance and support quality oversight activities
• Plan, conduct, and report on domestic and international audits of investigator sites and vendors, while supporting inspection readiness initiatives

Required Qualifications

• BA/BS degree in biological sciences or a related field
• Minimum of 6+ years of experience in the pharmaceutical or biotechnology industry
• At least 4+ years of GCP-related Quality Assurance or relevant clinical trial experience
• Strong knowledge of ICH-GCP, GLP, GVP, FDA, and EMA regulations
• Experience conducting and managing GCP audits of investigator sites and clinical systems