Associate Director, GxP Validation & Compliance

Scorpion Therapeutics; California (MO); On-site; USD 186,000 - 233,000; Full time

Job summary

Scorpion Therapeutics in Redwood City, CA, is seeking an Associate Director, IS Quality and Compliance to lead GxP computerized system validation within the Information Sciences organization.

This role oversees CSV/CSA activities, regulatory compliance, risk-based validation strategies, validation lifecycle deliverables, and audit-readiness initiatives, while mentoring validation teams and partnering with Quality and Business Owners.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related.
• 12+ years supporting GxP computerized systems.
• Expertise in CSV/CSA, data integrity, GxP regulations (FDA 21 CFR Part 11, EU Annex 11).
• Experience managing complex validation programs and supporting inspections.

Responsibilities

• Oversee CSV/CSA activities, regulatory compliance, develop risk-based validation strategies.
• Manage validation lifecycle deliverables, and lead audit-readiness initiatives.
• Lead and mentor validation teams, collaborate with Quality and Business Owners, and improve validation practices.

Skills

GxP compliance

Regulatory knowledge

People leadership

Education

Bachelor's in Life Sciences, Engineering, or related

Tools

Veeva

NetSuite

IT security basics (NIST/ISO 27001)

Job description

Scorpion Therapeutics in Redwood City, CA, is seeking an Associate Director, IS Quality and Compliance to lead GxP computerized system validation within the Information Sciences organization.

This role oversees CSV/CSA activities, regulatory compliance, risk-based validation strategies, validation lifecycle deliverables, and audit-readiness initiatives, while mentoring validation teams and partnering with Quality and Business Owners.