Senior Quality Assurance Associate - GMP/GDP Auditing

Scorpion Therapeutics; United States; Remote; USD 90,000 - 140,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Quality Assurance Associate with expertise in GMP and GDP auditing to help ensure regulatory compliance with external partners and suppliers.

You will conduct onsite, remote, and hybrid audits of contract manufacturers, testing labs, and logistics providers, prepare audit reports, track CAPAs, and review supplier documentation. Collaboration with Technical Operations, Regulatory Affairs, and other teams is essential.

Qualifications

• 5+ years QA experience in FDA-regulated environments.
• 3+ years GMP/GDP audit experience.
• Familiarity with supplier oversight and regulatory inspections.

Responsibilities

• Audit contract manufacturers, testing labs, and logistics providers onsite, remotely, or in hybrid modes.
• Prepare audit reports and track CAPAs to closure.
• Review supplier documentation and performance metrics; collaborate with Technical Operations, Supply Chain, and Regulatory Affairs.

Skills

QA auditing

GxP compliance

GMP/GDP auditing

Education

Bachelor’s in Life Sciences, Engineering, or related field

Tools

Veeva Vault

Job description

Role: Senior Quality Assurance Associate specializing in GMP and GDP auditing within biopharma. Objectives include executing risk-based audits of external partners, supporting supplier qualification, and ensuring inspection readiness to maintain regulatory compliance.

Responsibilities encompass conducting onsite, remote, and hybrid audits of contract manufacturing, testing labs, and logistics providers; preparing audit reports, tracking CAPAs, and reviewing supplier documentation and performance metrics. The role requires collaboration with Technical Operations, Supply Chain, Regulatory Affairs, and other teams.

Qualifications

• Bachelor’s in Life Sciences, Engineering, or related field
• 5+ years QA experience in FDA-regulated environments
• 3+ years GMP/GDP audit experience
• familiarity with supplier oversight, regulatory inspections, and electronic QMS systems (Veeva Vault preferred)

Preferred certifications include Lead Auditor (ASQ, IRCA, Exemplar Global).

High-value biopharma specifics

focus on external supplier audits, qualification, and compliance in a rare disease setting, with an emphasis on GxP systems, inspection readiness, and cross-functional stakeholder engagement.

Location

Remote, with 25-40% travel domestically and internationally.