Senior GMP Supplier Quality Leader

United Therapeutics Corporation; North Carolina, United States, Northern America, Americas; Hybrid; USD 120,000 - 160,000; Full time

Job summary

United Therapeutics Corporation seeks an experienced leader to establish and manage the Supplier Quality program across multiple sites. You will ensure external partners meet cGMP standards, oversee supplier qualification, audits, CAPA, and continuous improvement initiatives.

The role requires strong regulatory knowledge, vendor management, and ability to lead cross-functional teams in a fast-paced biotech environment. Experience with FDA QMSR and 21 CFR guidance is highly valued.

Qualifications

• Bachelor's degree in science or equivalent required.
• Master's degree or PhD/PharmD preferred for advanced roles.
• Minimum 8+ years in QA with vendor oversight experience; 5+ years preferred in supplier management.

Responsibilities

• Establish, maintain, and improve the Supplier Quality program across sites.
• Oversee supplier qualification, audits, and CAPA in collaboration with GMP teams.
• Develop and monitor vendor scores, RFT and quality metrics; manage change notifications.

Skills

Vendor oversight

GxP knowledge

Auditing

Regulatory compliance

Leadership

Education

Bachelor's degree

Master's degree

PhD/PharmD

Tools

MS Office

DocuSign

Electronic QMS systems

Job description

United Therapeutics Corporation seeks an experienced leader to establish and manage the Supplier Quality program across multiple sites. You will ensure external partners meet cGMP standards, oversee supplier qualification, audits, CAPA, and continuous improvement initiatives.

The role requires strong regulatory knowledge, vendor management, and ability to lead cross-functional teams in a fast-paced biotech environment. Experience with FDA QMSR and 21 CFR guidance is highly valued.