Director, GxP Quality Assurance Job at Meet Life Sciences, Sonoma, CA

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  • Meet Life Sciences
  • Sonoma, CA

Job Description

*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 sarah.viall@meetlifesciences.com.

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