Sr Mgr, QA, Q Systems & Product Complaints
$165,000–$205,000 year
On-siteSouth San Francisco, California, United States
Job Summary
Lead Rigel's Product Complaint Management Program, overseeing complaint intake, investigation, documentation, closure, and reconciliation while coordinating cross-functional teams with contract manufacturers and testing laboratories. Serve as Quality System Owner for the CAPA Program, managing root cause analysis, action planning, and effectiveness checks to ensure timely completion. Provide Quality oversight of Pharmacovigilance vendors, call centers, and external service providers through performance monitoring, audits, and quality review meetings. Support Health Authority inspections, partner compliance audits, and ongoing inspection readiness by preparing documents and developing responses. Analyze complaint data and quality metrics to identify trends, escalate significant risks, and drive continuous improvement of the Pharmaceutical Quality System.
Required Qualifications
- Bachelor's degree in a scientific, technical, or related discipline
- Minimum eight years of progressive Quality Assurance, Product Complaint Management, Quality Systems, or related GxP experience within the pharmaceutical, biotechnology, or life sciences industry
- Demonstrated experience leading product complaint investigations and Quality Systems, including CAPA, investigations, and deviations
- Working knowledge of applicable cGMP regulations, FDA 21 CFR Parts 210 and 211, ICH guidelines, and global regulatory requirements governing Product Complaint Management
- Experience providing Quality oversight of outsourced service providers and supporting Health Authority inspections and quality audits
- Strong investigation, root cause analysis, risk assessment, and problem-solving skills
- Demonstrated ability to analyze quality metrics, identify trends, and drive continuous improvement
- Strong organizational, project management, and communication skills, with the ability to collaborate effectively across functions and with external partners
- Demonstrated ability to manage multiple competing priorities while maintaining sound quality judgment, exceptional attention to detail, and a proactive, solution-oriented approach
- Some travel may be required
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