Auditor II, Global GMP/GDP Audits & Compliance (Candidates local to RTP or Silver Spring ONLY)
United Therapeutics Corporation
August 06, 2026
Remote friendly (Raleigh-Durham-Chapel Hill Area)
United States
Corporate Functions
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.
Minimum Requirements:
- 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).
Preferred Qualifications:
- 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, MasterControl).
Benefits:
- 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.
- 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.
Minimum Requirements:
- 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).
Preferred Qualifications:
- 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, MasterControl).
Benefits:
- 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.