Vice President, Quality Operations – Combination Products
United Therapeutics Corporation
June 30, 2026
On-site
Raleigh-Durham-Chapel Hill Area
Operations
How you’ll contribute
The Vice President, Quality Operations - Combination Products will oversee Quality functions for Dry Powder Inhalation and Soft Mist Inhaler production facilities, ensuring drug products and medical devices meet global GMP/GDP regulations and UT quality standards.
- Oversee Quality Operations for manufacturing, labeling, and packaging compliance with GMP/GDP and global standards
- Provide quality leadership to facilitate timely product disposition
- Ensure compliance with FDA and other applicable global regulations
- Lead quality activities for facility start-up (equipment qualification, process validation, regulatory filings)
- Manage Health Authority inspections and audit readiness
- Collaborate with Manufacturing on quality standards for functionality and patient safety
- Oversee/approve GMP documentation (batch records, deviations, validation protocols, regulatory filings)
- Build/maintain Quality Agreements with manufacturing vendors and device suppliers
- Adapt quality systems for combination product requirements (design control, risk management, post-market surveillance)
- Drive CAPAs via risk assessments to improve product/process quality
- Lead cross-functional technology transfer for seamless drug/device integration
- Drive continuous improvement while maintaining compliance
- Collaborate with supply chain to ensure uninterrupted, high-quality supply
- Represent Quality in leadership meetings; communicate goals/progress
- Monitor and integrate emerging combination product regulatory requirements
- Develop/maintain training for quality staff on combination product regulations and systems
- Partner with Manufacturing, Regulatory Affairs, and Engineering for scale-up and global regulatory submissions
- All other duties as required
Minimum Requirements
- Bachelor’s degree in a scientific discipline (or equivalent experience/training)
- 15+ years quality experience in pharma/fine chemicals (progressive responsibility)
- 10+ years management (5+ years overseeing QA and QC)
- 7+ years FDA/USP/EP testing requirements
- 5+ years stability testing
- Instrumentation expertise (HPLC, GC, UV/VIS, FTIR)
- US FDA, EU, and JP GMP experience
- Analytical method development/validation; lab method transfer
- Equipment qualification (IQ/OQ/PQ) protocol review, writing, and application
- Departmental budgeting; advanced cGMP knowledge
- Strong organizational skills, attention to detail, prioritization, and ability to work independently and cross-functionally
- MS Office proficiency (Word, Excel)
Preferred Qualifications
- Master’s degree in a scientific discipline (or equivalent experience/training)
Job Location / Instructions
- On-site 100% at RTP, North Carolina (27713); relocation assistance may be available for non-local candidates.
The Vice President, Quality Operations - Combination Products will oversee Quality functions for Dry Powder Inhalation and Soft Mist Inhaler production facilities, ensuring drug products and medical devices meet global GMP/GDP regulations and UT quality standards.
- Oversee Quality Operations for manufacturing, labeling, and packaging compliance with GMP/GDP and global standards
- Provide quality leadership to facilitate timely product disposition
- Ensure compliance with FDA and other applicable global regulations
- Lead quality activities for facility start-up (equipment qualification, process validation, regulatory filings)
- Manage Health Authority inspections and audit readiness
- Collaborate with Manufacturing on quality standards for functionality and patient safety
- Oversee/approve GMP documentation (batch records, deviations, validation protocols, regulatory filings)
- Build/maintain Quality Agreements with manufacturing vendors and device suppliers
- Adapt quality systems for combination product requirements (design control, risk management, post-market surveillance)
- Drive CAPAs via risk assessments to improve product/process quality
- Lead cross-functional technology transfer for seamless drug/device integration
- Drive continuous improvement while maintaining compliance
- Collaborate with supply chain to ensure uninterrupted, high-quality supply
- Represent Quality in leadership meetings; communicate goals/progress
- Monitor and integrate emerging combination product regulatory requirements
- Develop/maintain training for quality staff on combination product regulations and systems
- Partner with Manufacturing, Regulatory Affairs, and Engineering for scale-up and global regulatory submissions
- All other duties as required
Minimum Requirements
- Bachelor’s degree in a scientific discipline (or equivalent experience/training)
- 15+ years quality experience in pharma/fine chemicals (progressive responsibility)
- 10+ years management (5+ years overseeing QA and QC)
- 7+ years FDA/USP/EP testing requirements
- 5+ years stability testing
- Instrumentation expertise (HPLC, GC, UV/VIS, FTIR)
- US FDA, EU, and JP GMP experience
- Analytical method development/validation; lab method transfer
- Equipment qualification (IQ/OQ/PQ) protocol review, writing, and application
- Departmental budgeting; advanced cGMP knowledge
- Strong organizational skills, attention to detail, prioritization, and ability to work independently and cross-functionally
- MS Office proficiency (Word, Excel)
Preferred Qualifications
- Master’s degree in a scientific discipline (or equivalent experience/training)
Job Location / Instructions
- On-site 100% at RTP, North Carolina (27713); relocation assistance may be available for non-local candidates.