Senior Quality Auditor - cGMP & Vendor Oversight

United Therapeutics Corporation; United States; On-site; USD 88,000 - 135,000; Full time

Job summary

United Therapeutics Corporation seeks a Quality Assurance Auditor to conduct audits of quality management systems, oversee supplier qualifications, and ensure cGMP compliance across development to commercialization. The role involves evaluating CMOs, preparing risk assessments, and coordinating with QA teams.

Located near RTP, NC or Silver Spring, MD, with up to 50% travel to manage cGMP activities and site/vendor compliance audits. Strong regulatory knowledge and communication skills required.

Qualifications

• Bachelor’s degree in science or engineering field.
• 5+ years auditing and supplier management in FDA-regulated industry.
• Strong knowledge of US cGMP and associated ISO/ICH standards.
• Must have a valid passport.
• Ability to work independently and in a multifunctional team.
• Excellent written and verbal communication with management.
• Strong computer skills (MS Office).
• Experience auditing sterile, solid dose or biologic manufacturing is a plus.

Responsibilities

• Conduct audits of quality management systems across manufacturing, packaging, and facilities.
• Develop risk-based audit schedules and detailed audit reports with findings.
• Perform internal audits of UT facilities from development through commercialization.
• Assess GMP/GDP CMOs and vendors for regulatory compliance.
• Prepare vendor risk assessments and control plans.
• Manage GxP Vendor List reviews and approvals.
• Coordinate with CMOs and vendors, investigate quality issues with QA management guidance.
• Support development projects to ensure cGMP compliance at launch.
• Receive and disseminate Vendor Change Notifications.
• Monitor quality system performance including vendor performance.
• Review UT procedures to align with regulations and guidelines.
• Assist in developing initial GMP/GDP supplier agreements.

Skills

Auditing experience

Strong communication

Independent worker

Multifunctional team player

Attention to detail

Organizational skills

Prioritization skills

Documentation & reporting

Education

Bachelor’s Degree in science or engineering

Master’s Degree

PhD in science or engineering

Tools

SAP

TrackWise Digital

MasterControl

Job description

United Therapeutics Corporation seeks a Quality Assurance Auditor to conduct audits of quality management systems, oversee supplier qualifications, and ensure cGMP compliance across development to commercialization. The role involves evaluating CMOs, preparing risk assessments, and coordinating with QA teams.

Located near RTP, NC or Silver Spring, MD, with up to 50% travel to manage cGMP activities and site/vendor compliance audits. Strong regulatory knowledge and communication skills required.