Quality Executive Director

About the position

The Quality Executive Director is responsible for leading all GxP (GMP, GCP, GLP) quality functions for Rigel Pharmaceuticals, a pharmaceutical company with contracted manufacturing through CDMOs. This role ensures compliance with regulatory requirements and drives quality excellence across manufacturing, clinical, safety and laboratory operations. Reporting to the Vice President of Compliance and Quality, the Executive Director provides strategic and operational leadership to the quality organization and fosters partnerships with CDMOs and CROs.

Responsibilities

• Enhance and implement a comprehensive GxP quality management strategy.
• Oversee quality agreements with CDMOs and CROs to ensure regulatory and contractual compliance.
• Drive GxP governance, ensuring alignment with corporate and regulatory standards (FDA, EMA, ICH).
• Maintain oversight of GMP, GCP, and GLP activities, ensuring regulatory compliance.
• Oversee investigations, CAPAs, change controls, and risk management processes.
• Lead supplier and partner qualification, including CDMOs and CROs.
• Develop, monitor, and manage supplier Key Performance Indicators (KPIs) to measure quality performance and drive improvements.
• Develop and manage audit programs covering CDMOs and CROs.
• Lead regulatory inspection readiness efforts and oversee post-inspection follow-ups.
• Direct and mentor a multidisciplinary quality team spanning GxP disciplines.
• Collaborate with cross-functional teams, including Clinical Operations, Manufacturing, and Regulatory Affairs.
• Support regular updates and quality performance to Rigel's Management Committee and to the Board of Directors.
• Use operational KPIs to identify trends, areas for improvement, and opportunities for optimization.
• Drive quality improvement initiatives to enhance efficiency and compliance.
• Stay current on regulatory changes and integrate best practices into the organization.

Requirements

• Bachelor's degree in a life science discipline (Master's or advanced degree preferred).
• Minimum 15 years in pharmaceutical quality assurance, with 7+ years in a senior leadership role.
• Proven experience in GxP oversight and managing CDMO and CRO relationships.
• Strong knowledge of GxP regulations (GMP, GCP, GLP) and global regulatory standards.
• Excellent leadership and communication skills.
• Strategic mindset with experience managing complex quality systems.