QA/QC Manager - DPF - Houston

United Therapeutics•Houston, TX

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, supporting xenotransplantation organ manufacturing. The role governs the site environmental monitoring program and leads deviation and CAPA management for microbiology and on-site QA functions. It requires hands-on quality leadership, expertise in QA, QC microbiology, and environmental monitoring, and the ability to identify risk, solve problems, and maintain compliance in a highly regulated environment. The manager oversees QA/QC programs supporting regulatory and clinical efforts toward FDA approval of advanced therapeutic products. Responsibilities include environmental monitoring, microbiological testing, on-site QA oversight, inspection readiness, controlled-document and quality-record approval, investigations and CAPAs, supplier qualification, audits, validation support, and quality-system improvement. The role partners with Site Operations, Animal Care, Facilities, and other teams, and represents QA in product development, technology transfer, and scale-up activities. It also supports regulatory inspections and may require review of clinical case data outside normal business hours. This position is located 100% onsite at the company’s Houston, Texas facility. Eligible employees may participate in the company’s benefits programs, including medical, dental, vision, and prescription coverage; wellness resources; savings plans; paid time off; paid parental leave; and disability benefits.

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, with the ability to apply requirements to company-specific processes, products, and preservation of lungs.
Applied expertise in cGMP requirements, environmental monitoring program governance, and QC microbiology operations.
Experience supporting FDA, USDA, and other agency regulatory inspections 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; 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 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 Quality Management System.

Responsibilities

Manage Quality Assurance and Quality Control 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.
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 using risk-based prioritization.
Partner with Site Operations, Animal Care, and Facilities to align microbiology and environmental monitoring controls with operational realities and risk; provide Quality input on facility, process, and equipment changes.
Establish operational metrics and dashboards for the QA/QC microbiology function and report performance, risks, and trends to senior Quality leadership.
Drive supplier qualification for critical microbiological consumables, media, reagents, and contract testing 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 activities, including deviation and failure investigations, change control documentation, complaints, SOPs, and product quality reviews.
Lead risk assessments and CAPA programs to proactively address quality issues and prevent recurrence.
Lead controlled-document collaboration, review, and approval within the electronic document management system.
Perform real-time review of clinical case data, 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; assess internal processes for efficiency.
Assist management during FDA and other regulatory inspections, interpret inspection direction, respond to potential issues, and support timely and accurate transfer of data and documents to inspectors.