On-Site QA/QC Manager – Microbiology & Compliance

United Therapeutics Corporation; Christiansburg (VA); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical/dental/vision coverage

401(k) with ESPP

Paid time off

Parental leave

Disability benefits

Job summary

United Therapeutics Corporation in Christiansburg, VA, is seeking a QA/QC Manager for the Designated Pathogen-Free (DPF) facility to lead on-site QA and QC microbiology, environmental monitoring, and deviation/CAPA management. The role supports inspection readiness and regulatory compliance within a GMP/QSR environment.

The position requires 8+ years in GMP/QSR settings or 6+ with an advanced degree; collaboration with Site Operations, Animal Care, and Facilities is essential for risk-based

Qualifications

• Experience in GMP/QSR regulatory environment.
• Ability to apply GxP principles to xenotransplantation procedures.
• Experience reviewing deviations, CAPAs, change controls, and quality records.
• Experience supporting FDA/EMA/ISO audits.

Responsibilities

• Lead QA/QC microbiology programs and environmental monitoring.
• Oversee deviations, CAPA, change control, and audit files.
• Support regulatory inspections and inspection readiness activities.
• Develop and track QA metrics and KPIs; report risks to leadership.

Skills

GMP/QSR knowledge

Regulatory inspections experience

Root cause analysis

Environmental monitoring governance

Quality metrics & dashboards

Cross-functional collaboration

Education

Bachelor's Degree in Life Sciences or related

Master's Degree in related field

Tools

MasterControl/eDMS

TrackWise

Job description

United Therapeutics Corporation in Christiansburg, VA, is seeking a QA/QC Manager for the Designated Pathogen-Free (DPF) facility to lead on-site QA and QC microbiology, environmental monitoring, and deviation/CAPA management. The role supports inspection readiness and regulatory compliance within a GMP/QSR environment.

The position requires 8+ years in GMP/QSR settings or 6+ with an advanced degree; collaboration with Site Operations, Animal Care, and Facilities is essential for risk-based