What are the responsibilities and job description for the Director, Quality Assurance Compliance position at Rigel Pharmaceutical, Inc.?
POSITION SUMMARY:
The Director, QA Compliance, is responsible for ensuring Rigels GxP compliance across GMP, GCP, GLP, and GPvP domains. This role oversees the internal audit program, inspection readiness activities, and complaint management processes. The Director interfaces closely with Medical Affairs, CMC, Regulatory, Clinical Operations, Pharmacovigilance, and the Call Center. This position drives continuous improvement in quality systems and maintains alignment with global regulatory expectations.
Salary Range: $210,000 to $250,000
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Lead Rigels vendor/supplier audit program, while this role is not expected to lead every audit conducted by Rigel, serving as an Audit Lead is an important element of this role.
Lead Rigel inspection and partner audit readiness activities for GxP areas
Lead Rigel complaint management program to ensure effective tracking, investigation, escalation, resolution, reconciliation, and trending of product complaints. Drive collaboration between QA, CMC/Technical Operations, Medical Affairs, Pharmacovigilance, and the Call Center.
Ensure completeness, accuracy, and appropriate escalation of product complaints, identify and drive CAPAs, when appropriate.
Analyze and present complaint data at Rigel Safety Committee.
Serve as QA representative for post-market quality activities, ensuring alignment between GMP and GPvP systems.
Manage Rigel Quality Escalation process: setting up and facilitating quality review board or equivalent governance meetings
Lead Rigel inspection readiness efforts and oversee inspection response management.
Partner with Rigel Clinical Operations to drive adherence to Good Clinical Practice (GCP) guidelines and regulatory standards through activities like audits, SOP development, Quality Agreements implementation, etc.
Monitor compliance metrics and identify trends to inform risk-based quality improvements.
Ensure global regulatory changes are evaluated and integrated into Rigels QMS.
Provide training and compliance guidance to QA and cross-functional teams.
KNOWLEDGE AND SKILL REQUIREMENTS:
Bachelors degree in scientific discipline.
12 years of pharmaceutical QA experience with focus on compliance, audits, and complaint management. GMP and GCP experience is desired.
Comprehensive understanding of FDA, EMA, and ICH regulations for GMP, GCP, and GPvP.
Experience managing complaint and CAPA systems, and supporting regulatory inspections.
Strong analytical and organizational skills with attention to detail.
Excellent communication and stakeholder management skills across technical and non-technical teams.
Demonstrated ability to lead continuous improvement and compliance initiatives.
WORKING CONDITIONS:
- PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk, sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.
- WORK ENVIRONMENT: The noise level in the work environment is usually moderate. Some travel may be required.
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 : $210,000 - $250,000