Senior Director of Quality

Job Summary

To lead all GxP Quality activities, the fully remote Senior Director of Quality will oversee GMP, GLP, and GCP quality across internal teams and external partners, ensuring product integrity, patient safety, and regulatory compliance as the PAH program advances through clinical development.

Key responsibilities

• Develop and execute the Quality strategy for the PAH program, ensuring alignment with clinical, regulatory, and CMC milestones
• Build a scalable, phase-appropriate Quality Management System (QMS) and serve as the senior Quality advisor to executive leadership
• Ensure GCP compliance across all clinical trials, leading clinical vendor audits and supporting site inspection readiness

Required qualifications

• Bachelor's degree in life sciences or related field; advanced degree preferred
• 15+ years of progressive GxP Quality experience in biotech/pharma, including leadership roles
• Strong experience overseeing external manufacturing and managing CDMOs
• Demonstrated success preparing for and leading global regulatory inspections
• Deep knowledge of FDA, EMA, ICH regulations; experience with PAH, cardiopulmonary, or rare disease programs preferred but not required