Associate Director, Quality Assurance - Regenerative Organ Manufacturing (RMOMAL)
United Therapeutics Corporation
August 22, 2026
On-site
Raleigh-Durham-Chapel Hill Area
Operations
Responsibilities:
- Provide strategic and operational leadership for Quality Assurance for the RMOMAL regenerative organ manufacturing program (Pre-IND through IND-enabling milestones, subsequent BLA submission, and commercialization).
- Develop QA strategy and translate it into operational plans for the RMOMAL QA/QC organization.
- Initiate and lead phase-appropriate QMS build-out and IND-readiness initiatives.
- Serve as QA representative for IND-enabling gap assessments (CMC/GMP, regulatory strategy, clinical readiness, quality systems); support Pre-IND meetings and RMAT designation.
- Own planning, staffing, budgeting, and expenses for RMOMAL Quality Assurance.
- Lead and develop the RMOMAL QA/QC team (QA Manager; QA Specialists, QC Supervisor, QC Analyst).
- Own and continuously improve the phase-appropriate Quality Management System (SOPs, forms, training, document hierarchy).
- Ensure compliance with data integrity (ALCOA+) and applicable regulatory frameworks (21 CFR Parts 600–680, 1271, 11; ICH Q9/Q10).
- Oversee deviation/failure investigations, CAPA, change control, complaints, and product quality reviews; track KPIs and risk.
- Review regulated documentation for accuracy, completeness, and compliance with GMP/cGTP/QSR/Clinical Trial requirements.
- Support validation protocol/report development (process validation, MCB generation, aseptic process simulation) and QA dispositions.
- Lead controlled document review/approval in the electronic document management system.
- Negotiate/manage Quality Agreements and Manufacturing/Supply Agreements with external partners (including 21 CFR Part 1271 cell banking).
- Oversee partner performance via audits, supplier qualification, and monitoring; lead/support internal and vendor/CMO audits and corrective actions.
- Assist during FDA/other regulatory inspections; interpret direction and respond to mitigate issues.
- Stay current on regenerative medicine/tissue engineering/cell therapy/organ manufacturing technologies and regulatory trends.
Minimum Qualifications:
- Bachelor’s degree (technical/scientific); 12+ years related experience (or 10+ years with a Master’s).
- 6+ years people management experience.
- Experience contributing to IND/BLA (or similar) for cell/tissue-based regenerative medicine or organ manufacturing.
- Applied cGMP/cGTP/QSR/FDA knowledge; ability to apply GxP to novel/emerging modalities.
- Experience with MCB generation, aseptic process simulation (APS), or cell banking QA oversight.
- Proven experience building/implementing a QMS in Pre-IND or early clinical-stage environments.
- Experience negotiating/managing Quality Agreements and Manufacturing/Supply Agreements with CMOs/test labs.
- Strong risk assessment, analytical judgment, and problem-solving.
- Ability to mentor/coach and resolve conflicts; strong change management.
- Excellent technical/professional documentation and cross-functional communication.
- Expertise preparing for/managing FDA, EMA, and ISO audits.
Preferred Qualifications:
- Master’s degree (technical/scientific).
- Proficiency: MS Excel, PowerPoint, Word, Outlook; AI prompt engineering/tools.
- Experience with donor eligibility/biovigilance/HCT/P (21 CFR Part 1271).
- Experience with TrackWise, MasterControl (eDMS); working knowledge of LIMS.
- Ability to lead organizational change and apply Lean/Six Sigma.
Benefits (if eligible): Medical/dental/vision/prescription coverage; wellness resources; 401(k) and ESPP; paid time off; paid parental leave; disability benefits.
- Provide strategic and operational leadership for Quality Assurance for the RMOMAL regenerative organ manufacturing program (Pre-IND through IND-enabling milestones, subsequent BLA submission, and commercialization).
- Develop QA strategy and translate it into operational plans for the RMOMAL QA/QC organization.
- Initiate and lead phase-appropriate QMS build-out and IND-readiness initiatives.
- Serve as QA representative for IND-enabling gap assessments (CMC/GMP, regulatory strategy, clinical readiness, quality systems); support Pre-IND meetings and RMAT designation.
- Own planning, staffing, budgeting, and expenses for RMOMAL Quality Assurance.
- Lead and develop the RMOMAL QA/QC team (QA Manager; QA Specialists, QC Supervisor, QC Analyst).
- Own and continuously improve the phase-appropriate Quality Management System (SOPs, forms, training, document hierarchy).
- Ensure compliance with data integrity (ALCOA+) and applicable regulatory frameworks (21 CFR Parts 600–680, 1271, 11; ICH Q9/Q10).
- Oversee deviation/failure investigations, CAPA, change control, complaints, and product quality reviews; track KPIs and risk.
- Review regulated documentation for accuracy, completeness, and compliance with GMP/cGTP/QSR/Clinical Trial requirements.
- Support validation protocol/report development (process validation, MCB generation, aseptic process simulation) and QA dispositions.
- Lead controlled document review/approval in the electronic document management system.
- Negotiate/manage Quality Agreements and Manufacturing/Supply Agreements with external partners (including 21 CFR Part 1271 cell banking).
- Oversee partner performance via audits, supplier qualification, and monitoring; lead/support internal and vendor/CMO audits and corrective actions.
- Assist during FDA/other regulatory inspections; interpret direction and respond to mitigate issues.
- Stay current on regenerative medicine/tissue engineering/cell therapy/organ manufacturing technologies and regulatory trends.
Minimum Qualifications:
- Bachelor’s degree (technical/scientific); 12+ years related experience (or 10+ years with a Master’s).
- 6+ years people management experience.
- Experience contributing to IND/BLA (or similar) for cell/tissue-based regenerative medicine or organ manufacturing.
- Applied cGMP/cGTP/QSR/FDA knowledge; ability to apply GxP to novel/emerging modalities.
- Experience with MCB generation, aseptic process simulation (APS), or cell banking QA oversight.
- Proven experience building/implementing a QMS in Pre-IND or early clinical-stage environments.
- Experience negotiating/managing Quality Agreements and Manufacturing/Supply Agreements with CMOs/test labs.
- Strong risk assessment, analytical judgment, and problem-solving.
- Ability to mentor/coach and resolve conflicts; strong change management.
- Excellent technical/professional documentation and cross-functional communication.
- Expertise preparing for/managing FDA, EMA, and ISO audits.
Preferred Qualifications:
- Master’s degree (technical/scientific).
- Proficiency: MS Excel, PowerPoint, Word, Outlook; AI prompt engineering/tools.
- Experience with donor eligibility/biovigilance/HCT/P (21 CFR Part 1271).
- Experience with TrackWise, MasterControl (eDMS); working knowledge of LIMS.
- Ability to lead organizational change and apply Lean/Six Sigma.
Benefits (if eligible): Medical/dental/vision/prescription coverage; wellness resources; 401(k) and ESPP; paid time off; paid parental leave; disability benefits.