QA/QC Manager - DPF - Houston

Unither Pharmaceuticals•Houston, TX

3d•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 in Houston, 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 calls for a hands-on quality leader with expertise in QA, QC microbiology, and environmental monitoring who can identify risks, solve problems, and maintain compliance in a highly regulated environment. The position manages QA/QC programs supporting regulatory and clinical efforts toward FDA approval of advanced therapeutic products. Responsibilities include oversight of environmental monitoring and microbiological testing, inspection readiness, controlled documents and quality records, investigations and CAPAs, supplier qualification, audits, validation activities, and quality-system improvements. The manager collaborates with Site Operations, Animal Care, Facilities, Operations, Quality, and R&D, and represents QA in product development, technology transfer, and scale-up activities. The role may require review of clinical case data and procedures outside normal business hours and is 100% onsite at the Houston, Texas facility.

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, including applying requirements to company processes, products, and preservation of lungs.
Applied expertise in cGMP requirements, environmental monitoring program governance, and QC microbiology operations.
Experience supporting regulatory inspections, including 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; 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 other personnel, communicate problems and deficiencies, elicit corrections, and enforce company policies and procedures.
Expertise preparing for and managing FDA, EMA, and ISO audits.
Ability to work 100% onsite at the Houston, Texas facility.

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 aimed at 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.
Act as a senior QA approver of controlled documents in MasterControl and quality records in TrackWise.
Lead or oversee root cause analyses 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 needs and risk, and provide Quality input on facility, process, and equipment changes.
Establish operational metrics and dashboards, and report performance, risks, and trends to senior Quality leadership on a recurring basis.
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 in the electronic document management system.
Review clinical case data in real time, including procedures and data outside normal business hours when required.
Support Operations, Quality, and R&D in preparing validation protocols and reports, and 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, help mitigate potential issues, and support accurate and timely transfer of data and documents to inspectors.