Senior Director of Quality

Job Summary

Leading all GxP Quality activities for the Pulmonary Arterial Hypertension (PAH) program, the fully remote Senior Director of Quality will develop and execute a Quality strategy, oversee GMP and GCP compliance, and build a scalable Quality Management System while serving as the primary quality authority for the organization.

Key responsibilities

• Develop and execute the Quality strategy for the PAH program, ensuring alignment with clinical and regulatory milestones
• Oversee all GMP activities and manage CDMO and CTL oversight, including audits and performance monitoring
• Prepare the PAH program for regulatory inspections and ensure continuous inspection readiness across all GxP domains

Required qualifications

• Bachelor's degree in life sciences or related field; advanced degree preferred
• 10-15+ 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, and ICH regulations, with experience in PAH or cardiopulmonary programs preferred