QA/QC Manager - DPF - Stewartville

United Therapeutics Corporation•Stewartville, MN

3d•$100,000 - $140,000•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 United Therapeutics’ Designated Pathogen-Free (DPF) facility, supporting xenotransplantation organ manufacturing. The role governs the site’s environmental monitoring program and leads deviation and CAPA management for microbiology and on-site QA functions. It manages QA/QC programs supporting regulatory and clinical efforts toward FDA approval of advanced therapeutic products and helps maintain inspection readiness and continuous improvement. The position oversees environmental monitoring in barrier and non-barrier areas, microbiological testing, on-site QA oversight, controlled-document and quality-record approval, investigations, corrective actions, supplier qualification, audits, quality metrics, and validation support. It partners with Site Operations, Animal Care, Facilities, Operations, and R&D, and represents QA in product development, technology transfer, and scale-up activities. The manager also supports regulatory inspections and may review clinical case data outside normal business hours. This position is 100% onsite at the Stewartville, Minnesota facility. The stated salary range is $100,000–$140,000 per year.

Requirements

At least 8 years of experience in a GMP/QSR-regulated environment with a bachelor’s degree, or at least 6 years with a master’s degree.
Applied knowledge of GMP/QSR, FDA regulations, GxP principles, and industry standards, including applying requirements to company-specific processes, products, and lung preservation.
Applied expertise in cGMP requirements, environmental monitoring program governance, and QC microbiology operations.
Experience supporting regulatory inspections by the FDA, USDA, and other agencies as a subject matter expert.
Direct experience reviewing and approving controlled documents, deviations, CAPAs, change controls, and quality records in electronic quality systems.
Experience leading root cause analysis for microbiological and environmental events and familiarity with risk-based decision-making, such as ICH Q9 principles.
Strong analytical judgment and exceptional problem-solving and risk-assessment capabilities.
Ability to interpret data and apply GxP principles to xenotransplantation-specific procedures, processes, and products.
Experience reviewing or auditing medical and Quality records.
Ability to review work performed by others, communicate problems and deficiencies, elicit corrections, and enforce company policies and procedures.
Expertise 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 QA/QC programs supporting regulatory and clinical efforts toward FDA approval for advanced therapeutic products.
Provide operational leadership for the on-site QA/QC microbiology function, including environmental monitoring, microbiological testing, on-site QA oversight, and inspection readiness.
Govern environmental monitoring for barrier and non-barrier areas, including program design review, qualification, trending, signal detection, and continuous improvement.
Approve controlled documents in MasterControl and quality records in TrackWise.
Lead or oversee root cause analysis for microbiological and environmental events, and drive timely CAPA execution and effectiveness verification using risk-based prioritization.
Partner with Site Operations, Animal Care, and Facilities to align microbiology and environmental monitoring controls with operational requirements and risk; provide Quality input on facility, process, and equipment changes.
Establish operational metrics and dashboards for QA/QC microbiology and report performance, risks, and trends to senior Quality leadership.
Drive supplier qualification for critical microbiological consumables, media, reagents, and contract test laboratories; support supplier audits as needed.
Support DPF Quality Management System initiatives, inspection readiness, right-first-time execution, and continuous improvement.
Represent QA in product development meetings, technology transfer, and scale-up activities.
Perform internal and vendor audits, track corrective actions, manage audit files, and summarize data for annual product reports.
Conduct QA oversight, including deviation and failure investigations, change-control documentation, complaints, SOPs, and product quality reviews.
Lead risk assessments and CAPA programs to address quality issues and prevent recurrence.
Lead controlled-document collaboration, review, and approval in the electronic document management system.
Establish and track key quality indicators and present trends and risk analyses to senior leadership.
Review clinical case data in real time, which may require procedure and data review outside normal business hours.
Support Operations, Quality, and R&D in preparing validation protocols and reports; coordinate validation plans and tasks to complete projects on time.
Develop and guide new initiatives and quality improvements, and assess internal processes for efficiency.
Assist management during FDA and other regulatory inspections, interpret inspection direction, support timely and accurate transfer of data and documents to inspectors, and act with discretion.