Director, Clinical Quality Assurance
Location: Flexible (US-based)

A rapidly growing biotech company advancing cutting-edge therapies for rare diseases is seeking a Director of Clinical Quality Assurance (CQA) to build and lead its GCP compliance strategy. Reporting to the Head of Quality, this is a high-impact leadership role responsible for designing and executing clinical quality systems across a portfolio of global early-phase gene therapy trials.

Key Responsibilities:

Lead GCP oversight for all clinical programs, ensuring global regulatory compliance (FDA, EMA, WHO, etc.)
Build and scale clinical quality systems, processes, and frameworks in a fast-moving environment
Conduct and manage audits of CROs, vendors, and clinical trial sites
Collaborate cross-functionally with internal teams and external partners to ensure inspection readiness and continuous improvement
Support clinical operations with risk mitigation strategies and timely resolution of quality issues
Serve as a strategic quality partner across the business, fostering a culture of compliance and quality excellence

Core Requirements:

8+ years of GCP and clinical quality experience in biotech or pharma
5+ years in progressive leadership roles, including oversight of Phase 1-3 trials
Deep experience auditing CROs and managing global clinical quality programs
Familiarity with regulatory agency interactions (FDA, EMA, others)
Strong background in early clinical-stage environments; startup experience preferred
Exposure to immunology and gene therapy trials is strongly preferred
Bachelor's or Master's in life sciences or related discipline

This is a rare opportunity to build a fit-for-purpose clinical quality function at a mission-driven company focused on expanding global access to transformative therapies.

If you're ready to shape quality strategy and execution from the ground up in a fast-growing biotech, apply today.

Confidential inquiries welcome.