Sr. Manager QA, Quality Systems & Product Complaints
Rigel Pharmaceuticals Inc.
August 26, 2026
Remote friendly (South San Francisco, CA)
United States
Operations
Position Summary
- Lead Rigel’s Product Complaint Management Program, including oversight of Pharmacovigilance interfaces and external complaint-handling service providers.
- Serve as Quality System Owner for Rigel’s CAPA Program and support inspection readiness, Health Authority inspections, and partner audits to ensure compliance with applicable regulatory requirements and continuous improvement of the Pharmaceutical Quality System.
Essential Duties and Responsibilities
Quality Systems and Oversight
- Serve as Quality System Owner for the CAPA Program; ensure CAPAs are initiated, evaluated, implemented, monitored, and closed.
- Review/approve CAPAs; guide CAPA owners on root cause analysis, action planning, effectiveness checks, and timely completion.
- Monitor CAPA performance and recommend improvements.
- Provide Quality oversight of Pharmacovigilance vendors/call center and other complaint-handling providers (performance monitoring, quality review meetings, audits, review of quality events).
- Provide Quality oversight of Pharmacovigilance deviations and associated CAPAs.
Compliance and Inspection Readiness
- Support inspection readiness.
- Support Health Authority inspections (document preparation, assigned QA Systems presentation, response development, implementation of inspection commitments).
- Support partner compliance audits and participate in vendor/provider audits.
Product Complaint Management
- Lead product complaint intake, assessment, investigation, documentation, closure, and reconciliation.
- Coordinate cross-functional investigations with internal teams and external partners (e.g., contract manufacturers, testing labs, distributors).
- Ensure investigations meet established timelines and regulatory requirements.
- Evaluate complaints for quality impact and potential quality signals; escalate significant issues.
- Analyze complaint data/trends/metrics and communicate risks and recommendations.
- Develop, maintain, and deliver Product Complaint Management training.
Knowledge and Skill Requirements
- Bachelor’s degree in scientific/technical/related discipline.
- Minimum 8 years progressive QA, Product Complaint Management, Quality Systems, or related GxP experience in pharma/biotech/life sciences.
- Experience leading product complaint investigations and Quality Systems (CAPA, investigations, deviations).
- Working knowledge of cGMP, FDA 21 CFR Parts 210/211, ICH, and global regulatory requirements for product complaint management.
- Experience overseeing outsourced service providers and supporting Health Authority inspections and quality audits.
- Strong investigation, root cause analysis, risk assessment, and problem-solving skills.
- Ability to analyze quality metrics, identify trends, and drive continuous improvement.
- Strong organization, project management, and communication; ability to collaborate across functions and externally.
- Ability to manage multiple priorities with sound quality judgment and detail-oriented, proactive approach.
Compensation and Benefits
- Salary range: National $165,000–$205,000; Premium (SFBA/NYC/Boston) $185,000–$225,000.
- Eligible for annual bonus program and equity incentive awards (non-commission).
- Comprehensive benefits: medical/dental/vision, life/disability, flexible spending accounts, 401(k), paid time off, paid holidays, and other benefits.
- Lead Rigel’s Product Complaint Management Program, including oversight of Pharmacovigilance interfaces and external complaint-handling service providers.
- Serve as Quality System Owner for Rigel’s CAPA Program and support inspection readiness, Health Authority inspections, and partner audits to ensure compliance with applicable regulatory requirements and continuous improvement of the Pharmaceutical Quality System.
Essential Duties and Responsibilities
Quality Systems and Oversight
- Serve as Quality System Owner for the CAPA Program; ensure CAPAs are initiated, evaluated, implemented, monitored, and closed.
- Review/approve CAPAs; guide CAPA owners on root cause analysis, action planning, effectiveness checks, and timely completion.
- Monitor CAPA performance and recommend improvements.
- Provide Quality oversight of Pharmacovigilance vendors/call center and other complaint-handling providers (performance monitoring, quality review meetings, audits, review of quality events).
- Provide Quality oversight of Pharmacovigilance deviations and associated CAPAs.
Compliance and Inspection Readiness
- Support inspection readiness.
- Support Health Authority inspections (document preparation, assigned QA Systems presentation, response development, implementation of inspection commitments).
- Support partner compliance audits and participate in vendor/provider audits.
Product Complaint Management
- Lead product complaint intake, assessment, investigation, documentation, closure, and reconciliation.
- Coordinate cross-functional investigations with internal teams and external partners (e.g., contract manufacturers, testing labs, distributors).
- Ensure investigations meet established timelines and regulatory requirements.
- Evaluate complaints for quality impact and potential quality signals; escalate significant issues.
- Analyze complaint data/trends/metrics and communicate risks and recommendations.
- Develop, maintain, and deliver Product Complaint Management training.
Knowledge and Skill Requirements
- Bachelor’s degree in scientific/technical/related discipline.
- Minimum 8 years progressive QA, Product Complaint Management, Quality Systems, or related GxP experience in pharma/biotech/life sciences.
- Experience leading product complaint investigations and Quality Systems (CAPA, investigations, deviations).
- Working knowledge of cGMP, FDA 21 CFR Parts 210/211, ICH, and global regulatory requirements for product complaint management.
- Experience overseeing outsourced service providers and supporting Health Authority inspections and quality audits.
- Strong investigation, root cause analysis, risk assessment, and problem-solving skills.
- Ability to analyze quality metrics, identify trends, and drive continuous improvement.
- Strong organization, project management, and communication; ability to collaborate across functions and externally.
- Ability to manage multiple priorities with sound quality judgment and detail-oriented, proactive approach.
Compensation and Benefits
- Salary range: National $165,000–$205,000; Premium (SFBA/NYC/Boston) $185,000–$225,000.
- Eligible for annual bonus program and equity incentive awards (non-commission).
- Comprehensive benefits: medical/dental/vision, life/disability, flexible spending accounts, 401(k), paid time off, paid holidays, and other benefits.