Senior QA Auditor: GMP & Supplier Quality

Scorpion Therapeutics; Chapel Hill (NC); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical/dental/vision coverage

401(k)/ESPP

Paid time off & parental leave

Job summary

Scorpion Therapeutics seeks an experienced quality auditor to ensure robust QMS across sites and GMP/GDP suppliers. You will conduct audits, prepare risk assessments, and support regulatory alignment from development through commercialization.

The role requires 5+ years of supplier auditing in FDA-regulated environments, strong cGMP knowledge, and the ability to work independently within cross-functional teams. Passport and willingness to travel may be required.

Qualifications

• Bachelor’s degree in science/engineering.
• 5+ years auditing/managing suppliers in FDA-regulated medical device/pharma environments.
• Strong cGMP knowledge (21 CFR Parts 4, 11, 210, 211, QMSR) and familiarity with ISO/ICH.
• Valid passport (or ability to obtain).
• Strong attention to detail; can work independently and on multifunctional teams.
• Strong organization/prioritization and communication (verbal/written) with internal/external stakeholders.
• Computer skills (Microsoft Office: Word/Excel/PowerPoint).

Responsibilities

• Ensure appropriate quality systems at UT sites and with approved GMP/GDP suppliers via internal audits, supplier qualification/surveillance audits, Quality Agreements support, regulatory inspection support, and assigned quality improvement initiatives.
• Conduct initial and routine audits of QMS elements (manufacturing/packaging, facilities, distribution, analytical processes, technical reports, design history files); perform mock pre-approval inspections as needed.
• Create risk-based audit schedules/plans; write audit reports; evaluate audit responses/corrective actions; follow up on issues and track ongoing cGMP compliance.
• Perform internal audits across the product lifecycle (development to commercialization).
• Assess/audit current and prospective GMP/GDP CMOs/vendors for compliance with UT standards and GMP/GDP regulations.
• Prepare vendor risk assessments and risk control plans; review supplier quality events/change notifications to maintain product/vendor quality history.
• Oversee the GxP Vendor List; review/approve new material part numbers and vendor requests.
• Coordinate with internal stakeholders; assist investigations of quality issues (as directed by QA).
• Support development projects for cGMP compliance at launch (participate in teams, train personnel, prioritize vendor qualifications).
• Receive/assess/disseminate Vendor Change Notifications; monitor and report QMS performance.
• Review/evaluate UT procedures for regulatory alignment; assist with initial supplier Agreements.

Skills

Auditing

Supplier management

cGMP knowledge

Communication

MS Office

Education

Bachelor’s degree in science/engineering

Master’s or PhD in science/engineering

Tools

SAP

Trackwise Digital

MasterControl

Job description

Scorpion Therapeutics seeks an experienced quality auditor to ensure robust QMS across sites and GMP/GDP suppliers. You will conduct audits, prepare risk assessments, and support regulatory alignment from development through commercialization.

The role requires 5+ years of supplier auditing in FDA-regulated environments, strong cGMP knowledge, and the ability to work independently within cross-functional teams. Passport and willingness to travel may be required.