QA Director, Regenerative Organ Manufacturing

United Therapeutics Corporation; North Carolina; On-site; USD 150,000 - 190,000; Full time

Job summary

United Therapeutics Corporation in RTP, NC leads regenerative organ manufacturing QA for a pre-clinical to IND-enabling program. This role provides strategic QA leadership for RMOMAL, building a phase-appropriate QMS and guiding the QA/QC staff toward quality and compliance.

The Associate Director partners with Cell Biology, Process Engineering, Regulatory Affairs and leadership to drive inspections, right-first-time execution, and continuous improvement in a fast-evolving program, with heavy

Qualifications

• Bachelor’s degree in a technical or scientific discipline; extensive QA/GxP experience.
• Experience contributing to IND/BLA or regulatory submissions in regenerative medicine.
• Proven leadership of QA teams in pre-commercial or early clinical environments.

Responsibilities

• Provide strategic and operational QA leadership for RMOMAL from Pre-IND to IND readiness.
• Develop, implement, and mature a phase-appropriate QMS for organ manufacturing.
• Lead QA/QC staff, drive CAPA, change control, and supplier quality oversight.
• Coordinate audits with CMOs and respond to regulatory inspections effectively.
• Collaborate across functions to ensure data integrity and regulatory readiness.

Skills

Leadership

Quality assurance

Program management

Regulatory knowledge

Education

Bachelor's degree in a technical field

Master's degree preferred

Tools

MasterControl

TrackWise

LIMS

Excel

Job description

United Therapeutics Corporation in RTP, NC leads regenerative organ manufacturing QA for a pre-clinical to IND-enabling program. This role provides strategic QA leadership for RMOMAL, building a phase-appropriate QMS and guiding the QA/QC staff toward quality and compliance.

The Associate Director partners with Cell Biology, Process Engineering, Regulatory Affairs and leadership to drive inspections, right-first-time execution, and continuous improvement in a fast-evolving program, with heavy