QA​/QC Manager - DPF

## QA/QC Manager - DPFApplyremote type:
On-Site locations:
Christiansburg, VAtime type:
Full time posted on:
Posted Todayjob requisition :
R05187

California, US residents .
** The job details are as follows:
** Who We Are    We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

Who You Are    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 Master Control and quality records in Track Wise
- 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…