Auditor II, Global GMP​/GDP Audits & Compliance; local to RTP or Silver

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.

• 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).

• Master’s or PhD in science/engineering.
• ASQ Certified Quality Auditor or ISO lead auditor; RAC-RAPS.
• Experience auditing sterile/solid dose/biologic manufacturing.
• Experience reviewing device development documents/Design History Files; knowledge of electronic QMS (SAP, Trackwise Digital, Master Control).

Comprehensive benefits suite including medical/dental/vision/prescription coverage, wellness resources, 401(k)/ESPP, paid time off and paid parental leave, disability benefits, and more.