Sr. Manager QA, Quality Systems & Product Complaints

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The Senior Manager, Quality Assurance, Quality Systems & Product Complaints is responsible for leading Rigel’s Product Complaint Management Program, including oversight of Pharmacovigilance interfaces and external complaint-handling service providers. The role also serves as Quality System Owner for Rigel’s CAPA Program and supports inspection readiness, Health Authority inspections, and partner audits to ensure compliance with applicable regulatory requirements and drive continuous improvement of the Pharmaceutical Quality System.

National $165,000 to $205,000

Premium (SFBA/NYC/Boston Area) $185,000 to $225,000

• Serve as Quality System Owner for Rigel's CAPA Program, ensuring CAPAs are appropriately initiated, evaluated, implemented, monitored, and closed in accordance with Quality System requirements.
• Review and approve CAPAs and provide guidance to CAPA owners regarding root cause analysis, action planning, effectiveness checks, and timely completion.
• Monitor CAPA Program performance and recommend improvements to strengthen program effectiveness.
• Provide Quality oversight of Pharmacovigilance vendors, call center providers, and other complaint-handling service providers through performance monitoring, quality review meetings, audits, and review of quality events.
• Provide Quality oversight of Pharmacovigilance deviations and associated corrective and preventive actions, as applicable.

• Support Health Authority inspections, including document preparation, presentation of assigned Quality Systems, response development, and implementation of inspection commitments.
• Support the hosting of partner compliance audits of Rigel.
• Participate in audits of vendors, call center providers, and other applicable external service providers.

• Lead Rigel's Product Complaint Management Program, ensuring complaints intake, assessment, investigation, documentation, closure, and reconciliation of product complaints.
• Coordinate cross-functional product complaint investigations with internal subject matter experts, contract manufacturers, testing laboratories, distributors, and other business partners.
• Ensure complaint investigations are completed in accordance with established timelines, applicable procedures, and regulatory requirements.
• Evaluate product complaints for quality impact and potential product quality signals, ensuring timely escalation of significant quality issues.
• Analyze complaint data, trends, and quality metrics and communicate emerging risks and recommendations to QA leadership and cross-functional stakeholders.
• Develop, maintain, and deliver training related to Product Complaint Management.

• 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.

The anticipated salary range for this position is National $165,000 to $205,000 and, if applicable, Premium Market (SFBA/NYC/Boston Area) $185,000 to $225,000. The actual salary offered will depend on several factors, including experience, qualifications, geographic location, internal equity, and business needs.

This position is eligible to participate in Rigel's annual bonus program and is eligible for equity incentive awards, subject to the terms of the applicable plans. This position is not commission-based.

Rigel offers eligible employees a comprehensive benefits package, including medical,…