Associate Director, IS Quality and 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

Role: Associate Director, IS Quality and Compliance

leading GxP computerized system validation within the Information Sciences organization of a biopharma company focused on oncology and RAS-targeted therapies.

Responsibilities

• oversee CSV/CSA activities, ensure regulatory compliance, develop risk-based validation strategies, manage validation lifecycle deliverables, and lead audit-readiness initiatives.
• Lead and mentor validation teams, collaborate with cross-functional stakeholders including Quality and Business Owners, and continuously improve validation practices.

Required

• Bachelor's 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), and validation methodologies;
• experience managing complex validation programs and supporting inspections.

Preferred

• experience with cloud-based GxP systems, enterprise applications (e.g., Veeva, NetSuite), and leading multinational validation projects;
• familiarity with IT security standards like NIST and ISO 27001.

HighValue

• regulated GxP environment, computerized system lifecycle, audit and inspection support, cloud/SaaS validation, and cross-region leadership.

Work Setup

WorkSetup: onsite at Redwood City, CA, with salary range $186K-$233K; travel expectations not specified.