Associate Director, Quality Assurance - Regenerative Organ Manufacturing (RMOMAL

Position: Associate Director, Quality Assurance - Regenerative Organ Manufacturing (RMOMAL)
## Associate Director, Quality Assurance - Regenerative Organ Manufacturing (RMOMAL)
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On-Site locations:
RTP, NCtime type:
Full time posted on:
Posted Yesterday job requisition :
R05204

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 Associate Director, Quality Assurance – Regenerative Organ Manufacturing (RMOMAL) provides strategic and operational Quality leadership for United Therapeutics' regenerative organ manufacturing program, a pre-clinical, Pre-IND regenerative medicine program based at Research Triangle Park, NC. This role builds and matures a phase-appropriate Quality Management System for a novel HCT/P-adjacent manufacturing platform, leads and develops the RMOMAL QA/QC team, and serves as the primary Quality interface with external contract manufacturing and testing partners as the program advances toward IND-enabling milestones.

This position partners closely with Cell Biology, Process Engineering, Process Development, Regulatory Affairs, and executive leadership to drive inspection readiness, right-first-time execution, and continuous improvement in a fast-evolving, high-visibility program.
* Provide strategic and operational leadership for Quality Assurance activities supporting the RMOMAL regenerative organ manufacturing program, from Pre-IND through IND-enabling milestones, subsequent BLA submission and commercialization
* Contribute to the development of departmental and functional QA strategy for the Regenerative Organ Manufacturing program; translate strategy into operational and tactical plans for the RMOMAL QA/QC organization
* Initiate and lead departmental and certain interdepartmental strategic initiatives, including phase-appropriate QMS build-out and IND-readiness planning, with guidance from QA executive leadership
* Serve as QA representative and strategic contributor to IND-enabling gap assessments spanning CMC/GMP, regulatory strategy, clinical readiness, and quality systems work streams; support preparation for Pre-IND meetings and RMAT designation activities
* Responsible for overall planning, staffing, budgeting, and managing expenses for the RMOMAL Quality Assurance function
* Serve as the primary QA people leader for the RMOMAL organization; manage, coach, and develop the QA Manager and supporting QA/QC staff (QA Specialist, QC Supervisor, QC Analyst)
* Drive a culture of quality, accountability, ethical conduct, and continuous improvement across the RMOMAL QA/QC organization
* Own development, implementation, and continuous improvement of the phase-appropriate Quality Management System (QMS) for the ROM program, including SOPs, forms, training curricula, and document hierarchy
* Ensure compliance with data integrity principles (ALCOA+) and applicable…