Senior Supplier Quality Auditor - Remote (GxP & Regulatory)

Scorpion Therapeutics; New Jersey; On-site; USD 96,000 - 117,000; Full time

Benefits offered by this job

Comprehensive benefits

PTO & vacation time

Remote work within US

Job summary

Scorpion Therapeutics is seeking an experienced QA Auditor to lead supplier audits and ensure GxP compliance across GMP, GLP, and GCP frameworks. You will evaluate regulatory requirements, document findings, and drive CAPAs with cross-functional teams.

The role requires 7+ years in QA/auditing within pharma/biotech, strong regulatory knowledge, and willingness to travel domestically for supplier site audits. Remote work within the United States is supported.

Qualifications

• Bachelor’s degree or equivalent experience in Life Sciences or related field.
• Minimum 7 years’ experience in QA, auditing, or supplier management in pharma/biotech/cGMP.
• At least 3 years in auditing/QA in a GxP regulated environment; biotech/pharma preferred.
• Strong knowledge of global GxP regulations and standards (21 CFR 11/210/211; EudraLex Vol. 4; ICH).
• Experience auditing across GMP/GLP/GCP; identify systemic quality risks.

Responsibilities

• Plan, schedule, and conduct onsite and remote audits of suppliers and external service providers per the approved supplier audit program.
• Evaluate supplier compliance with regulatory requirements (FDA, EMA, ICH), internal SOPs, and quality agreements.
• Document audit observations and collaborate to develop CAPAs.
• Track CAPAs to closure and verify timely implementation and effectiveness.
• Maintain accurate supplier audit records; communicate audit results and risk assessments.
• Support regulatory inspections and inspection readiness related to supplier oversight.
• Provide guidance and training to suppliers and internal teams on audit processes and GxP expectations.
• Participate in continuous improvement initiatives for supplier quality oversight and audit processes.
• Domestic travel to supplier sites is required.

Skills

Quality assurance

Auditing

Regulatory compliance

GxP knowledge

Regulatory knowledge

Education

Bachelor’s degree in Life Sciences, Chemistry, or related field

Job description

Scorpion Therapeutics is seeking an experienced QA Auditor to lead supplier audits and ensure GxP compliance across GMP, GLP, and GCP frameworks. You will evaluate regulatory requirements, document findings, and drive CAPAs with cross-functional teams.

The role requires 7+ years in QA/auditing within pharma/biotech, strong regulatory knowledge, and willingness to travel domestically for supplier site audits. Remote work within the United States is supported.