Senior GxP Quality Auditing & Compliance Leader

Scorpion Therapeutics; Newark (CA); Hybrid; USD 140,000 - 210,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Scorpion Therapeutics is seeking an Associate Director, Quality Auditing & Compliance to lead the company's risk-based internal GxP audit program, ensuring adherence to regulatory standards, policies, and quality systems. You will develop audit plans across GxP areas, perform audits of internal and external entities, support inspections, drive CAPAs, and contribute to QMS improvements while collaborating with cross-functional teams.

Travel 30-40% to domestic and international sites.

Qualifications

• GxP auditing experience in pharma/biotech is required or strongly preferred.
• Strong knowledge of FDA, ICH and global regulations.

Responsibilities

• Develop and execute audit plans across GxP areas.
• Perform audits of internal and external entities and evaluate compliance.
• Partner with stakeholders on CAPAs and remediation.
• Support inspection readiness and regulatory inspections.
• Contribute to QMS improvements and compliance metrics.

Skills

GxP auditing

Regulatory compliance

Audit planning

Cross-functional influence

Education

Bachelor's degree in life sciences, pharmacy, engineering, or related field

Job description

Scorpion Therapeutics is seeking an Associate Director, Quality Auditing & Compliance to lead the company's risk-based internal GxP audit program, ensuring adherence to regulatory standards, policies, and quality systems. You will develop audit plans across GxP areas, perform audits of internal and external entities, support inspections, drive CAPAs, and contribute to QMS improvements while collaborating with cross-functional teams.

Travel 30-40% to domestic and international sites.