Remote Director, GxP Quality Assurance
Remote (West Coast working hours)
Our client is a late-stage biologics company focused on treatments for autoimmune diseases and cancer. They are looking for a Director of GxP QA to lead the quality team and help build a scalable quality management system to support their clinical and future commercial efforts.
Responsibilities
- Oversee and enhance GxP compliance across GMP, GCP, and GLP functions
- Lead development and implementation of the Quality Management System
- Manage quality processes: deviations, CAPAs, change control, audits, training, and documentation
- Support regulatory inspection readiness and ensure ongoing compliance
- Drive continuous improvement and risk-based decision-making across teams
- Partner cross-functionally on clinical development, tech transfer, and vendor oversight
Requirements
- Bachelor's or Master's in a relevant science or engineering field
- 4-6+ years of QA/GxP experience in biotech, pharma, CRO, or CDMO settings
- Deep knowledge of FDA, ICH, and international GxP regulations
- Experience building quality systems and managing regulatory compliance
- Strong communication, organizational, and problem-solving skills
- Inspection readiness, risk management, and operational excellence experience a plus
If you're interested in being considered for this role, please send a resume to (see below)