QA/QC Manager - DPF

United Therapeutics Corporation•Christiansburg, VA

2d•Onsite

About The Position

The QA/QC Manager provides operational and tactical leadership for the on-site Quality Assurance and Quality Control Microbiology function at the Designated Pathogen-Free (DPF) Facility in support of xenotransplantation organ manufacturing. This position is responsible for governing the environmental monitoring program at the site, leading deviation and CAPA management for the microbiology and on-site QA functions. - Manage Quality Assurance/Quality Control programs to support regulatory and clinical efforts aimed at achieving FDA approval for advanced therapeutic products - Provide operational leadership for the on-site QA / QC microbiology function at the DPF, including environmental monitoring, microbiological testing, on-site QA oversight, and inspection readiness - Govern the environmental monitoring program for barrier and non-barrier areas of the DPF, including program design review, qualification, periodic trending, signal detection, and continuous improvement - Serve as a senior QA approver of controlled documents in MasterControl and quality records in TrackWise - Lead or oversee root cause analysis for microbiological and environmental events; drive timely CAPA execution and effectiveness verification under risk-based prioritization - Partner with Site Operations, Animal Care, and Facilities to align microbiology and EM controls with operational reality and risk; provide Quality input on facility, process, and equipment changes - Establish operational metrics and dashboards for the QA / QC microbiology function; report performance, risks, and trends to senior Quality leadership on a recurring cadence - Drive supplier qualification activities for critical microbiological consumables, media, reagents, and contract test laboratories; support supplier audit programs as needed - Support strategic initiatives related to the DPF Quality Management System (QMS), inspection readiness, right-first-time execution, and continuous improvement - Act as QA representative in product development meetings, technology transfer, and scale-up activities - Perform internal and vendor audits; track corrective actions and manage audit files; summarize data for annual product reports - Conduct QA oversight activities, including deviation/failure investigations, change control documentation, complaints, SOPs, and product quality reviews - Lead risk assessments and Corrective and Preventive Action (CAPA) programs to proactively address quality issues and prevent recurrence - Lead controlled document collaboration, review, and approval within the electronic document management system - Establish and track key quality indicators (KPIs); present trends and risk analysis to senior leadership - Provide real-time review of clinical case data, which may require procedure and data review outside of normal business hours - Support Operations, Quality, and R&D in preparing validation protocols and reports; coordinate validation plans and tasks to ensure timely completion of projects - Develop and provide guidance on new initiatives and quality improvements; assess internal processes for efficiency - Assist management during FDA or other regulatory inspections; interpret inspection direction and respond quickly to mitigate potential issues; support timely and accurate data/document transfer to inspectors; act with discretion

Requirements

8+ years of experience in a GMP/QSR regulated environment with a Bachelor's Degree or 6+ years of experience in a GMP/QSR regulated environment with a Master's Degree
Applied knowledge of GMP/QSR, FDA regulations, GxP principles, and industry standards, with the ability to apply requirements to company-specific processes, products, and preservation of lungs
Demonstrated applied expertise in cGMP requirements, environmental monitoring program governance, and QC microbiology operations
Experience supporting regulatory inspections (FDA, USDA, and other agencies) as a subject matter expert
Direct experience reviewing and approving controlled documents, deviations, CAPAs, change controls, and quality records within electronic quality systems
Experience leading root cause analysis for microbiological and environmental events; familiarity with risk-based decision-making (e.g., ICH Q9 principles)
Strong analytical judgment with exceptional problem-solving and risk assessment capabilities
Ability to interpret data and apply GxP principles to xenotransplantation-specific procedures, processes, and products
Experience in review/audit of medical & Quality records
Exceptional skills in problem and risk analysis/assessments
Ability to review work performed by other personnel, communicate problems and deficiencies, elicit corrections, and enforce company policy and procedures
Expertise in preparing for and managing FDA, EMA, and ISO audits

Nice To Haves

Ability to lead organizational change related to quality systems and compliance
Experience contributing to IND, IDE, or BLA submissions
Experience with TrackWise and MasterControl (eDMS)
Experience creating and implementing a QMS

Responsibilities

Manage Quality Assurance/Quality Control programs to support regulatory and clinical efforts aimed at achieving FDA approval for advanced therapeutic products
Provide operational leadership for the on-site QA / QC microbiology function at the DPF, including environmental monitoring, microbiological testing, on-site QA oversight, and inspection readiness
Govern the environmental monitoring program for barrier and non-barrier areas of the DPF, including program design review, qualification, periodic trending, signal detection, and continuous improvement
Serve as a senior QA approver of controlled documents in MasterControl and quality records in TrackWise
Lead or oversee root cause analysis for microbiological and environmental events; drive timely CAPA execution and effectiveness verification under risk-based prioritization
Partner with Site Operations, Animal Care, and Facilities to align microbiology and EM controls with operational reality and risk; provide Quality input on facility, process, and equipment changes
Establish operational metrics and dashboards for the QA / QC microbiology function; report performance, risks, and trends to senior Quality leadership on a recurring cadence
Drive supplier qualification activities for critical microbiological consumables, media, reagents, and contract test laboratories; support supplier audit programs as needed
Support strategic initiatives related to the DPF Quality Management System (QMS), inspection readiness, right-first-time execution, and continuous improvement
Act as QA representative in product development meetings, technology transfer, and scale-up activities
Perform internal and vendor audits; track corrective actions and manage audit files; summarize data for annual product reports
Conduct QA oversight activities, including deviation/failure investigations, change control documentation, complaints, SOPs, and product quality reviews
Lead risk assessments and Corrective and Preventive Action (CAPA) programs to proactively address quality issues and prevent recurrence
Lead controlled document collaboration, review, and approval within the electronic document management system
Establish and track key quality indicators (KPIs); present trends and risk analysis to senior leadership
Provide real-time review of clinical case data, which may require procedure and data review outside of normal business hours
Support Operations, Quality, and R&D in preparing validation protocols and reports; coordinate validation plans and tasks to ensure timely completion of projects
Develop and provide guidance on new initiatives and quality improvements; assess internal processes for efficiency
Assist management during FDA or other regulatory inspections; interpret inspection direction and respond quickly to mitigate potential issues; support timely and accurate data/document transfer to inspectors; act with discretion