Associate Director, QA – Regenerative Organ Manufacturing

United Therapeutics Corporation; United States; On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

Health benefits

401k plan

Paid time off

Parental leave

Job summary

United Therapeutics Corporation seeks an Associate Director of Quality Assurance for the RMOMAL program in RTP, NC. This role provides strategic QA leadership through Pre-IND to IND- enabling milestones, partnering with regulatory, R&D, and manufacturing teams to ensure robust quality systems and inspection readiness.

You will oversee QA/QC staff, drive QMS development, data integrity, and collaboration with CMOs, with a focus on timely regulatory submissions and product quality improvements

Qualifications

• Bachelor’s degree in a technical or scientific discipline; advanced degree preferred.
• Experience contributing to IND/BLA submissions for cell- or tissue-based products.
• Strong knowledge of cGMP, cGTP, QSR, and FDA guidelines; GxP application to novel modalities.
• Ability to build and mature a Quality Management System in pre-commercial/IND phases.
• Excellent documentation skills and cross-functional collaboration.

Responsibilities

• Provide strategic and operational QA leadership for RMOMAL from Pre-IND through IND‑enabling milestones.
• Lead QA/QC organization and interface with CMOs and testing partners.
• Drive phase-appropriate QMS build‑out, including SOPs, forms, training curricula, and document hierarchy.
• Oversee deviation/investigation, CAPA, change control, complaints, and product quality reviews.
• Lead audits, supplier qualification, and ongoing performance monitoring; support regulatory inspections.

Skills

QA leadership

Regulatory strategy

GxP compliance

Audits & inspections

Documentation

Data integrity (ALCOA+)

Cross‑functional leadership

Mentoring managers

Education

Bachelor’s degree in a technical or scientific discipline

Master’s degree in a technical or scientific discipline

Tools

MS Excel

PowerPoint

Word

Outlook

TrackWise

MasterControl (eDMS)

Job description

United Therapeutics Corporation seeks an Associate Director of Quality Assurance for the RMOMAL program in RTP, NC. This role provides strategic QA leadership through Pre-IND to IND- enabling milestones, partnering with regulatory, R&D, and manufacturing teams to ensure robust quality systems and inspection readiness.

You will oversee QA/QC staff, drive QMS development, data integrity, and collaboration with CMOs, with a focus on timely regulatory submissions and product quality improvements