Associate Director, Quality Auditing & Compliance

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

Role

Associate Director, Quality Auditing & Compliance, leading the company’s risk-based internal GxP audit program to ensure adherence to regulatory standards, company policies, and quality systems.

Responsibilities

• develop and execute audit plans across GxP areas, perform audits of internal and external entities, evaluate compliance with FDA, ICH, and global regulations, and partner with stakeholders on CAPAs and remediation
• support inspection readiness and regulatory inspections
• contribute to QMS improvements and compliance metrics
• monitor industry practices

Requirements

• bachelor’s in life sciences, pharmacy, engineering, or related field
• 8-10 years in Quality Assurance or Compliance within pharma/biotech, with extensive GxP auditing experience
• strong knowledge of FDA, ICH, data integrity, and global regulations
• excellent communication skills and ability to influence cross-functional teams
• auditor certification preferred

HighValue

GxP audits, FDA and ICH compliance, quality systems, inspection readiness, global regulatory environment, 30-40% travel.

WorkSetup

hybrid Waltham, MA or Newark, CA, with domestic and international travel.