Onsite QA/QC Manager, Microbiology & EM

United Therapeutics Corporation; Stewartville (MN); On-site; USD 100,000 - 140,000; Full time

Job summary

United Therapeutics Corporation in Stewartville, MN, is seeking a QA/QC Manager for the Designated Pathogen-Free facility. The role provides operational leadership of QA/QC microbiology, environmental monitoring, and inspection readiness to support xenotransplantation manufacturing.

The successful candidate will govern EM programs, lead CAPA and deviation management, and partner with Site Operations to align microbiology controls with regulatory requirements.

Qualifications

• 8+ years in a GMP/QSR environment with a Bachelor's Degree or 6+ years with a Master's Degree.
• Applied knowledge of GMP/QSR, FDA regulations, GxP principles, and industry standards.
• Experience leading root cause analysis for microbiological and environmental events; risk-based decisions.
• Experience reviewing controlled documents, deviations, CAPAs, and quality records in QA systems.

Responsibilities

• Lead environmental monitoring program governance for the DPF site.
• Oversee microbiology testing and on-site QA oversight and inspection readiness.
• Drive deviation investigations, CAPA execution, and change controls.
• Prepare for FDA/EMA/ISO inspections and support regulatory submissions.
• Establish KPIs and dashboards; report trends to senior Quality leadership.
• Manage supplier qualification for microbiological consumables and audits.

Skills

GMP/QSR knowledge

GxP principles

Environmental monitoring governance

QC microbiology operations

Root cause analysis

CAPA & deviation management

Audit leadership

Regulatory inspections experience

TrackWise & MasterControl familiarity

Education

Bachelor's degree (GMP/QSR related)

Master's degree (preferred)

Tools

TrackWise

MasterControl

eDMS

Job description

United Therapeutics Corporation in Stewartville, MN, is seeking a QA/QC Manager for the Designated Pathogen-Free facility. The role provides operational leadership of QA/QC microbiology, environmental monitoring, and inspection readiness to support xenotransplantation manufacturing.

The successful candidate will govern EM programs, lead CAPA and deviation management, and partner with Site Operations to align microbiology controls with regulatory requirements.