Quality Assurance Manager - RMOMAL

Quality Assurance Manager - RMOMAL page is loaded## Quality Assurance Manager - RMOMALremote type:
On-Site locations:
RTP, NCtime type:
Full time posted on:
Posted Yesterday job requisition :
R04645

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
** You're an experienced quality professional excited about the challenge of supporting a greenfield site and creating a culture of quality and accountability from the ground up. You'll be supporting first of their kind regenerative organ products and will be uniquely challenged to apply your QA expertise in a brand new field. The Quality Assurance (QA) Manager will provide oversight and leadership for QA activities within a regenerative organ manufacturing GMP facility.

This role ensures compliance with FDA regulations, Good Manufacturing Practices (GMP), Quality System Regulations (QSR), and clinical trial requirements to support the development and commercialization of advanced therapeutic products. The QA Manager will collaborate cross-functionally to maintain a robust Quality Management System (QMS), drive continuous improvement, and support regulatory submissions and inspections.
* Manage Quality Assurance programs to support regulatory and clinical efforts aimed at achieving FDA approval for advanced therapeutic products
* Act as QA representative in product development meetings, technology transfer, and scale-up activities
* Ensure compliance with data integrity principles (ALCOA+) across electronic systems and laboratory records
* Drive process optimization and efficiency improvements using Lean or Six Sigma methodologies
* Review documentation (e.g., analytical/medical records, clinical case records, protocols, reports, environmental monitoring data, Device Design History Files, laboratory data) for accuracy, completeness, and compliance with company policies, procedures, and GMP/QSR/Clinical Trial requirements
* Oversee supplier qualification, audits, and ongoing performance monitoring to ensure raw materials and components meet GMP standards
* 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…