Associate Director, Quality Assurance - Regenerative Organ Manufacturing (RMOMAL)

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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 workstreams; 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 dual-jurisdiction regulatory frameworks — including 21 CFR Parts 600–680, Part 1271, Part 11, and ICH Q9/Q10 — across electronic systems and laboratory/manufacturing records
• Own Quality oversight for deviation/failure investigations, CAPA, change control, complaints, and product quality reviews; establish and track key quality indicators (KPIs) and present trends and risk analysis to senior leadership
• Review documentation (e.g., analytical/medical records, clinical case records, protocols, reports, environmental monitoring data, and laboratory data) for accuracy, completeness, and compliance with company policies, procedures, and GMP/cGTP/QSR/Clinical Trial requirements
• Support Operations, Quality, and R&D in preparation of validation protocols and reports (e.g., process validation, Master Cell Bank generation, aseptic process simulation); coordinate validation plans and provide QA disposition on validation deliverables
• Lead controlled document collaboration, review, and approval within the electronic document management system
• Lead negotiation, redlining, and ongoing management of Quality Agreements and Manufacturing/Supply Agreements with external contract manufacturing and testing partners, including cGTP-regulated cell banking activities under 21 CFR Part 1271
• Own Quality oversight of contract manufacturer and testing partner performance, including audits, supplier qualification, and ongoing performance monitoring
• Lead and/or support internal and vendor/CMO audits; manage audit files and track corrective actions to closure; summarize data to support annual product reviews
• Assist management during FDA or other regulatory inspections; interpret inspection direction and respond quickly to mitigate potential issues; support timely and accurate data/document transfer to inspectors; act with discretion
• Develop and provide guidance on new initiatives and quality improvements; assess internal processes and procedures to optimize resource utilization ahead of regulatory milestones
• Stay current on regenerative medicine, tissue engineering, cell therapy, and organ manufacturing technologies and regulatory trends to align QA practices with innovation

Minimum Requirements

• Bachelor’s Degree in a technical or scientific discipline
• 12+ years of related experience with a Bachelor's Degree or 10+ years of related experience with a Master's Degree
• 6+ people management experience, including experience managing managers and/or highly experienced individual contributors
• Experience contributing to IND, BLA, or similar regulatory submissions for cell- or tissue-based, regenerative medicine, or organ manufacturing products
• Applied knowledge of cGMP, cGTP, QSR, and FDA guidelines, with demonstrated ability to apply GxP principles to novel or emerging modalities (e.g., regenerative organ manufacturing, cell- or tissue-based products)
• Experience with Master Cell Bank (MCB) generation, aseptic process simulation (APS), or cell banking quality oversight
• Demonstrated experience building, implementing, or substantially maturing a Quality Management System in a pre-commercial, Pre-IND, or early clinical-stage environment
• Experience negotiating and managing Quality Agreements and Manufacturing/Supply Agreements with external contract manufacturing organizations (CMOs) or testing laboratories
• Strong analytical judgment with exceptional problem-solving and risk assessment capabilities; ability to interpret data in relation to company procedures and regulatory requirements (GMP/cGTP/QSR/GCP)
• Proven ability to mentor, coach, and develop QA managers and team members, with strong competency in conflict resolution and change management
• Excellent professional documentation skills; ability to objectively, accurately, and thoroughly convey complex issues in writing and produce a high volume of written materials independently
• Effective cross-functional collaboration and communication skills, including leading meetings and presentations to senior leadership
• Expertise in preparing for and managing FDA, EMA, and ISO audits

Preferred Requirements

• Master’s Degree in a technical or scientific discipline
• Proficiency in MS Excel, PowerPoint, Word, Outlook, AI Prompt engineering or AI tools
• Experience with donor eligibility, biovigilance, or Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) regulatory frameworks (21 CFR Part 1271)
• Ability to lead organizational change related to quality systems and compliance within a novel or emerging therapeutic modality
• Experience with TrackWise and MasterControl (eDMS); working knowledge of Laboratory Information Management Systems (LIMS)
• Ability to apply Lean or Six Sigma methodologies to drive process optimization

Job Location & Travel

United Therapeutics requires working in-person from our Research Triangle Park, NC facility when not on business travel.

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

United Therapeutics  Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.