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The job details are as follows:

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.

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