QA/QC Manager - DPF
United Therapeutics Corporation
August 15, 2026
On-site
Christiansburg, VA
Operations
Responsibilities:
- Provide operational and tactical leadership for on-site Quality Assurance/Quality Control microbiology at the DPF Facility supporting xenotransplantation organ manufacturing.
- Govern the site environmental monitoring program; lead deviation and CAPA management for microbiology and on-site QA.
- Manage QA/QC programs to support regulatory and clinical efforts toward FDA approval for advanced therapeutic products.
- Provide QA/QC microbiology operational leadership (environmental monitoring, microbiological testing, QA oversight, inspection readiness).
- Govern EM program for barrier and non-barrier areas (design review, qualification, trending, signal detection, continuous improvement).
- Review/approve controlled documents (MasterControl) and quality records (TrackWise).
- Lead/oversee root cause analysis for microbiological/environmental events; drive timely CAPA execution and effectiveness verification.
- Partner with Site Operations, Animal Care, and Facilities to align EM/microbiology controls with operational reality and risk; provide Quality input on facility/process/equipment changes.
- Establish QA/QC microbiology metrics/dashboards; report performance, risks, and trends to senior Quality.
- Drive supplier qualification for critical microbiological consumables/media/reagents and contract test labs; support audits.
- Support DPF QMS initiatives, inspection readiness, right-first-time execution, and continuous improvement.
- Act as QA representative in product development, technology transfer, and scale-up.
- Perform internal/vendor audits; track corrective actions and manage audit files; summarize data for annual product reports.
- Conduct QA oversight (deviations/failure investigations, change control documentation, complaints, SOPs, product quality reviews).
- Lead risk assessments and CAPA programs.
- Lead controlled document collaboration/review/approval in electronic document management system.
- Establish and track KPIs; present trends/risk analysis to leadership.
- Provide real-time review of clinical case data (may require after-hours work).
- Support validation protocols/reports; coordinate validation tasks.
- Develop guidance on quality initiatives; assess internal process efficiency.
- Assist with FDA/other regulatory inspections; interpret direction, respond quickly, and support timely data/document transfer.
Minimum Requirements:
- 8+ years (Bachelor’s) or 6+ years (Master’s) in GMP/QSR-regulated environment.
- Applied knowledge of GMP/QSR, FDA regulations, GxP; demonstrated cGMP expertise in EM governance and QC microbiology.
- Regulatory inspection experience (FDA/USDA/others) as SME.
- Experience reviewing/approving controlled documents, deviations, CAPAs, change controls, and quality records in electronic quality systems.
- Root cause analysis experience for microbiological/environmental events; risk-based decision-making (e.g., ICH Q9).
- Strong analytical judgment; ability to apply GxP to xenotransplantation procedures/products.
- Experience auditing/reviewing medical & quality records.
- Ability to review others’ work, communicate deficiencies, elicit corrections, and enforce SOPs.
- Expertise preparing for/managing FDA, EMA, and ISO audits.
Preferred Qualifications:
- Lead organizational change for quality systems/compliance.
- Experience with IND/IDE/BLA submissions.
- Experience with TrackWise and MasterControl (eDMS).
- Experience creating and implementing a QMS.
- Provide operational and tactical leadership for on-site Quality Assurance/Quality Control microbiology at the DPF Facility supporting xenotransplantation organ manufacturing.
- Govern the site environmental monitoring program; lead deviation and CAPA management for microbiology and on-site QA.
- Manage QA/QC programs to support regulatory and clinical efforts toward FDA approval for advanced therapeutic products.
- Provide QA/QC microbiology operational leadership (environmental monitoring, microbiological testing, QA oversight, inspection readiness).
- Govern EM program for barrier and non-barrier areas (design review, qualification, trending, signal detection, continuous improvement).
- Review/approve controlled documents (MasterControl) and quality records (TrackWise).
- Lead/oversee root cause analysis for microbiological/environmental events; drive timely CAPA execution and effectiveness verification.
- Partner with Site Operations, Animal Care, and Facilities to align EM/microbiology controls with operational reality and risk; provide Quality input on facility/process/equipment changes.
- Establish QA/QC microbiology metrics/dashboards; report performance, risks, and trends to senior Quality.
- Drive supplier qualification for critical microbiological consumables/media/reagents and contract test labs; support audits.
- Support DPF QMS initiatives, inspection readiness, right-first-time execution, and continuous improvement.
- Act as QA representative in product development, technology transfer, and scale-up.
- Perform internal/vendor audits; track corrective actions and manage audit files; summarize data for annual product reports.
- Conduct QA oversight (deviations/failure investigations, change control documentation, complaints, SOPs, product quality reviews).
- Lead risk assessments and CAPA programs.
- Lead controlled document collaboration/review/approval in electronic document management system.
- Establish and track KPIs; present trends/risk analysis to leadership.
- Provide real-time review of clinical case data (may require after-hours work).
- Support validation protocols/reports; coordinate validation tasks.
- Develop guidance on quality initiatives; assess internal process efficiency.
- Assist with FDA/other regulatory inspections; interpret direction, respond quickly, and support timely data/document transfer.
Minimum Requirements:
- 8+ years (Bachelor’s) or 6+ years (Master’s) in GMP/QSR-regulated environment.
- Applied knowledge of GMP/QSR, FDA regulations, GxP; demonstrated cGMP expertise in EM governance and QC microbiology.
- Regulatory inspection experience (FDA/USDA/others) as SME.
- Experience reviewing/approving controlled documents, deviations, CAPAs, change controls, and quality records in electronic quality systems.
- Root cause analysis experience for microbiological/environmental events; risk-based decision-making (e.g., ICH Q9).
- Strong analytical judgment; ability to apply GxP to xenotransplantation procedures/products.
- Experience auditing/reviewing medical & quality records.
- Ability to review others’ work, communicate deficiencies, elicit corrections, and enforce SOPs.
- Expertise preparing for/managing FDA, EMA, and ISO audits.
Preferred Qualifications:
- Lead organizational change for quality systems/compliance.
- Experience with IND/IDE/BLA submissions.
- Experience with TrackWise and MasterControl (eDMS).
- Experience creating and implementing a QMS.