Director, GLP Quality Assurance

Scorpion Therapeutics; California (MO); On-site; USD 211,000 - 264,000; Full time

Job summary

Scorpion Therapeutics, a late-stage oncology biopharma developing RAS-targeted therapies, is seeking a Director of GLP Quality Assurance. This onsite role in Redwood City, CA leads GLP QA across internal and external labs supporting clinical studies.

The candidate will develop audit plans, manage vendor QA, and ensure regulatory adherence including 21 CFR Part 58 and ICH GCP. Required are a Bachelor’s or Master’s degree and 12+ years of global GLP QA experience with strong audit management.

Qualifications

• Bachelor’s or Master’s degree required.
• 12+ years of global GLP QA experience required.
• Extensive audit management skills required.

Responsibilities

• Develop audit plans
• Perform/vendor audits
• Review study protocols and reports for compliance
• Monitor vendor QA activities
• Manage regulatory adherence (e.g., 21 CFR Part 58, OECD, ICH GCP)
• Provide GLP training and SOP development

Skills

Audit management

Regulatory knowledge

GLP QA

Vendor management

Biomarker lab knowledge

Education

Bachelor’s or Master’s degree

Tools

Computerized systems validation

Job description

Role

Director of GLP Quality Assurance at a late-stage oncology biopharma developing RAS-targeted therapies, responsible for ensuring GLP compliance across internal and external research labs supporting clinical studies.

Responsibilities

• Develop audit plans
• Perform/vendor audits
• Review study protocols and reports for compliance
• Monitor vendor QA activities
• Manage regulatory adherence (e.g., 21 CFR Part 58, OECD, ICH GCP)
• Provide GLP training and SOP development

Requirements

• Bachelor’s or Master’s degree
• 12+ years of global GLP QA experience
• Extensive audit management skills

Preferred

• RQAP-GLP certification
• Strong regulatory knowledge
• Experience with bioanalytical, PK, biomarker labs, and computerized systems validation

High Value

Experience with testing facilities, bioanalytical labs, biorepositories, and AI/ML in biomarker labs; knowledge of US and EU GLP/GCP regulations.

Collaboration

Liaises with vendors, internal nonclinical and clinical teams, and QA management.

Work Setup

Onsite in Redwood City, CA.

Salary range $211K-$264K, competitive benefits, and development opportunities.