Executive Director, GxP Quality and Compliance

Scorpion Therapeutics; California (MO); On-site; USD 250,000 - 320,000; Full time

Job summary

Scorpion Therapeutics seeks a Senior GxP Quality & Compliance Executive to drive global regulatory strategies for clinical and commercial oncology programs, including novel RAS-targeted therapies in development.

The role leads enterprise GxP programs, ensures inspection readiness, manages quality systems, mitigates risk, and partners with Regulatory Affairs, Clinical Development, and QA to support launches and market expansion.

Qualifications

• 15+ years in GxP Quality/Compliance within biotech/pharma
• 8+ years in senior leadership overseeing global compliance
• Extensive knowledge of FDA, EMA, ICH, and other international GxP requirements
• Proven success in regulatory inspections and building compliance frameworks

Responsibilities

• Develop and execute enterprise-wide GxP compliance programs
• Oversee inspection readiness
• Manage quality systems, risk mitigation, and supplier oversight
• Collaborate with Regulatory Affairs, Clinical Development, and Quality Assurance
• Advise senior leadership on compliance risks and regulatory interactions
• Support growth initiatives like product launches and market expansion

Skills

GxP Quality

Regulatory compliance

Leadership

Risk management

Inspection readiness

Quality systems

Supplier oversight

Education

PhD/MS in life sciences

Tools

Quality Management Software

Regulatory databases

Job description

Role: Senior GxP Quality & Compliance Executive leading global regulatory compliance strategies for clinical and commercial oncology products, including novel RAS-targeted therapies in development.

Responsibilities

develop and execute enterprise-wide GxP compliance programs, oversee inspection readiness, manage quality systems, risk mitigation, and supplier oversight; collaborate with cross-functional teams including Regulatory Affairs, Clinical Development, and Quality Assurance; advise senior leadership on compliance risks and regulatory interactions; support growth initiatives like product launches and market expansion.

Requirements

PhD, MS, or equivalent in life sciences; 15+ years in GxP Quality/Compliance within biotech/pharma, with 8+ years in senior leadership roles overseeing global compliance; extensive knowledge of FDA, EMA, ICH, and other international GxP requirements; proven success in regulatory inspections and building compliance frameworks.

High Value

experience with clinical and commercial GxP compliance, inspection readiness, biotech/oncology focus, global regulatory engagement, and digital compliance tools.

Work Setup

on-site in Redwood City, CA; up to 15% travel.