Senior QA Lead - CAPA & Product Complaints (Equity)

Scorpion Therapeutics; South San Francisco (CA); On-site; USD 165,000 - 225,000; Full time

Job summary

Scorpion Therapeutics seeks an experienced quality professional to lead the Product Complaint Management Program and own CAPA oversight, with responsibility for pharmacovigilance interfaces and external service providers. The role supports inspection readiness, Health Authority inspections, and partner audits to ensure regulatory compliance and continuous quality improvement.

The candidate will guide CAPA activities, oversee vendor quality, coordinate cross-functional investigations, and ensure

Qualifications

• Bachelor's degree in scientific/technical/related discipline.
• Minimum 8 years progressive QA, Product Complaint Management, Quality Systems, or related GxP experience.
• 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.

Responsibilities

• Lead product complaint intake, assessment, investigation, documentation, closure, and reconciliation.
• Coordinate cross-functional investigations with internal teams and external partners.
• 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.

Skills

QA leadership

CAPA management

Regulatory compliance

Root cause analysis

Quality metrics analysis

Cross-functional collaboration

Project management

Investigation skills

Education

Bachelor's degree in scientific/technical discipline

Tools

Quality Management System (QMS)

Job description

Scorpion Therapeutics seeks an experienced quality professional to lead the Product Complaint Management Program and own CAPA oversight, with responsibility for pharmacovigilance interfaces and external service providers. The role supports inspection readiness, Health Authority inspections, and partner audits to ensure regulatory compliance and continuous quality improvement.

The candidate will guide CAPA activities, oversee vendor quality, coordinate cross-functional investigations, and ensure