Manager, Global GMP Compliance
United Therapeutics Corporation
June 26, 2026
On-site
Raleigh-Durham-Chapel Hill Area
Operations
Responsibilities:
- Lead implementation, maintenance, and continuous improvement of a standardized regulatory intelligence process; perform cross-functional impact assessments.
- Monitor, assess, and interpret regulatory changes and compliance trends; translate into actionable recommendations; proactively communicate to stakeholders.
- Coordinate product recall process (planning, execution, documentation) and drive continuous improvement; maintain recall readiness via periodic mock recalls.
- Maintain KPI performance indicators and tools (e.g., Power BI) to build dashboards and report metrics to site management and executive leadership; prepare/deliver training on KPI tool use.
- Analyze compliance trends/metrics, identify risks/gaps, and provide clear data-driven reporting.
- Compile and interpret compliance data to support corporate management review.
- Lead Quality Management System improvement initiatives; track Quality Plan improvements and provide status/progress.
- Support emerging quality programs (e.g., Quality Maturity Index, Quality Risk assessment) and report Health Authority/Notified Body inspection-related metrics.
- Manage UTC-wide compliance initiatives (including ISO registration).
- Support regulatory inspections, including audit record initiation/follow-up; represent Global GMP Compliance during Health Authority inspections.
Minimum Requirements:
- Bachelor’s degree in a scientific/life science/related technical discipline.
- 8+ years in a regulated industry (biotech/pharma/medical devices/biologics) with a Bachelor’s OR 6+ years with a Master’s.
- 5+ years GMP Quality Assurance experience (CAPA, Change Control, Management Review, data analysis).
- Experience managing a regulatory intelligence program.
- Working knowledge of CFR 210, 211, 820, Part 11 and related FDA regulations.
- Experience with management review processes.
- Experience managing recalls/mock recalls.
- Experience monitoring/reporting compliance metrics/KPIs to senior management.
- Strong analytical, communication, and stakeholder skills.
Preferred Requirements:
- Master’s degree in engineering/chemistry/physical science.
- 3+ years as a Quality Assurance Manager in a GMP-regulated environment.
- Experience with QMS software (Trackwise Digital, MasterControl, etc.).
Job Location:
- On-site at RTP, North Carolina 100% of the time (with flexibility for one work-from-home day per week).
Benefits:
- Eligible employees may participate in medical/dental/vision/prescription coverage, wellness resources, savings plans (401k/ESPP), paid time off and paid parental leave, disability benefits, and more.
- Lead implementation, maintenance, and continuous improvement of a standardized regulatory intelligence process; perform cross-functional impact assessments.
- Monitor, assess, and interpret regulatory changes and compliance trends; translate into actionable recommendations; proactively communicate to stakeholders.
- Coordinate product recall process (planning, execution, documentation) and drive continuous improvement; maintain recall readiness via periodic mock recalls.
- Maintain KPI performance indicators and tools (e.g., Power BI) to build dashboards and report metrics to site management and executive leadership; prepare/deliver training on KPI tool use.
- Analyze compliance trends/metrics, identify risks/gaps, and provide clear data-driven reporting.
- Compile and interpret compliance data to support corporate management review.
- Lead Quality Management System improvement initiatives; track Quality Plan improvements and provide status/progress.
- Support emerging quality programs (e.g., Quality Maturity Index, Quality Risk assessment) and report Health Authority/Notified Body inspection-related metrics.
- Manage UTC-wide compliance initiatives (including ISO registration).
- Support regulatory inspections, including audit record initiation/follow-up; represent Global GMP Compliance during Health Authority inspections.
Minimum Requirements:
- Bachelor’s degree in a scientific/life science/related technical discipline.
- 8+ years in a regulated industry (biotech/pharma/medical devices/biologics) with a Bachelor’s OR 6+ years with a Master’s.
- 5+ years GMP Quality Assurance experience (CAPA, Change Control, Management Review, data analysis).
- Experience managing a regulatory intelligence program.
- Working knowledge of CFR 210, 211, 820, Part 11 and related FDA regulations.
- Experience with management review processes.
- Experience managing recalls/mock recalls.
- Experience monitoring/reporting compliance metrics/KPIs to senior management.
- Strong analytical, communication, and stakeholder skills.
Preferred Requirements:
- Master’s degree in engineering/chemistry/physical science.
- 3+ years as a Quality Assurance Manager in a GMP-regulated environment.
- Experience with QMS software (Trackwise Digital, MasterControl, etc.).
Job Location:
- On-site at RTP, North Carolina 100% of the time (with flexibility for one work-from-home day per week).
Benefits:
- Eligible employees may participate in medical/dental/vision/prescription coverage, wellness resources, savings plans (401k/ESPP), paid time off and paid parental leave, disability benefits, and more.