Senior GMP Quality Operations Leader

ProKidney Corp.; Winston-Salem (NC); On-site; USD 180,000 - 280,000; Full time

Job summary

ProKidney Corp. seeks a Senior Director, Quality Operations to provide strategic and hands-on leadership across GMP Quality Assurance for clinical and commercial drug product manufacturing.

You will supervise Manufacturing, Quality Control, and Warehouse/Distribution, ensuring data integrity, batch release readiness, and alignment with global regulatory requirements. This role drives audits, risk assessments, CAPAs, and continuous quality improvements.

Qualifications

• Bachelor’s degree in a scientific or allied health field.
• 10+ years of sterile manufacturing quality experience.
• Proven leadership in GMP quality environments.
• Experience with biologics, cell and gene therapy manufacturing.

Responsibilities

• Provide strategic quality oversight of Manufacturing Operations with a Quality-on-the-Floor presence.
• Oversee Quality Control laboratories for analytical readiness and data governance.
• Direct QA oversight of Warehouse, Materials, and Distribution operations.
• Ensure compliance with FDA, EMA, ICH and other global requirements.
• Lead internal and external audits and regulatory inspections.
• Review batch data and deviations to determine product disposition.
• Lead risk assessments and mitigation for GMP manufacturing.
• Support non-conformance/CAPA management and technical writing.
• Mentor and develop Quality and Manufacturing staff for growth.
• Input for continuous improvement of GMP quality systems.
• Collaborate across functions to address quality gaps and enhancements.
• Lead change control assessments for GMP manufacturing.

Skills

Quality leadership

GMP compliance

Regulatory knowledge (FDA/EMA)

Cross-functional leadership

Audit management

Risk assessment

Mentoring & development

Stakeholder communication

Education

Bachelor’s degree in a scientific or allied health field

Job description

ProKidney Corp. seeks a Senior Director, Quality Operations to provide strategic and hands-on leadership across GMP Quality Assurance for clinical and commercial drug product manufacturing.

You will supervise Manufacturing, Quality Control, and Warehouse/Distribution, ensuring data integrity, batch release readiness, and alignment with global regulatory requirements. This role drives audits, risk assessments, CAPAs, and continuous quality improvements.