What are the responsibilities and job description for the Quality Executive Director position at Rigel Pharmaceutical?
Position Overview:
The Executive Director of Quality 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.
Salary Range:
Premium CA & NY only $280,000 - $310,000
National $270,000 - $290,000
Key Responsibilities:
GxP Quality Oversight:
- 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).
Quality Systems & Compliance:
- 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.
Audits and Inspections:
- Develop and manage audit programs covering CDMOs and CROs.
- Lead regulatory inspection readiness efforts and oversee post-inspection follow-ups.
Leadership and Collaboration:
- Direct and mentor a multidisciplinary quality team spanning GxP disciplines.
- Collaborate with cross-functional teams, including Clinical Operations, Manufacturing, and Regulatory Affairs.
- Supports regular updates and quality performance to Rigels Management Committee and to the Board of Directors.
Continuous Improvement:
- 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.
Qualifications:
Education:
- Bachelors degree in a life science discipline (Masters or advanced degree preferred).
Experience:
- 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.
Skills and Competencies:
- 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.
Additional Requirements:
- Willingness to travel for site visits and audits.
- Ability to work in a fast-paced, highly regulated environment.
Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.
Salary : $270,000 - $290,000
