Clinical Quality Assurance Manager

We are partnering with a well-established, global biopharmaceutical organization with a strong clinical pipeline across oncology and specialty therapeutic areas. The company is entering an important growth phase within clinical development and expanding its Global Quality function.

They are seeking a Manager, GCP Quality Assurance to play a critical role in clinical compliance, audit execution, and inspection readiness across global Phase I–III programs.

This is a high-visibility position within a collaborative, cross-functional environment.

The Manager, GCP QA will serve as a key quality partner to Clinical Operations and external vendors, ensuring that clinical trials are conducted in compliance with ICH-GCP, FDA, and international regulatory requirements.

This individual will support inspection readiness strategy, manage quality events, and help strengthen GCP oversight processes across the organization.

• Lead and execute GCP audits (investigator sites, CROs, vendors, internal processes)
• Provide quality oversight across Phase I–III clinical trials
• Drive global inspection readiness activities
• Review and assess protocol deviations, quality events, and compliance risks
• Support CAPA development and effectiveness monitoring
• Partner cross-functionally with Clinical Operations, Regulatory, and Data Management
• Contribute to QMS enhancements and procedural improvements
• Provide GCP compliance guidance and training to internal stakeholders

• 5+ years in GCP Quality Assurance
• Strong hands-on GCP auditing experience
• Experience supporting global clinical trials
• Inspection readiness exposure for FDA and/or international health authorities
• Experience working within an electronic QMS platform
• Solid understanding of deviations, CAPAs, and risk-based quality management
• Ability to operate in a matrixed, fast-moving clinical environment

This is an excellent opportunity for a GCP Quality professional who wants ownership, inspection exposure, and the ability to influence clinical quality strategy within a growing organization.