Strategic Leader, GMP Quality Operations & Compliance

ProKidney; Winston-Salem (NC); On-site; USD 180,000 - 300,000; Full time

Job summary

ProKidney in Winston-Salem, North Carolina, seeks a Senior Director, Quality Operations to provide strategic and operational leadership across GMP Quality Assurance for clinical and commercial drug product manufacturing. This role ensures robust quality systems, data integrity, and readiness across manufacturing, QC, and distribution.

You will partner with Manufacturing and Regulatory to maintain inspection readiness, drive CAPA, and support Phase III IND manufacturing through commercial

Qualifications

• Bachelor’s degree in a scientific field with 10+ years of sterile manufacturing quality experience.
• Extensive GMP operational experience overseeing investigational drug manufacturing and aseptic processing.
• Proven ability to build, lead and develop GMP Quality Assurance teams.

Responsibilities

• Provide strategic quality oversight of Manufacturing Operations with Quality‑on‑the‑Floor presence and ensure cGMP compliance and data integrity.
• Oversee Quality Control laboratories for analytical readiness and timely testing to support production and release.
• Direct QA oversight of Warehouse, Materials, and Distribution including qualification, storage, inventory controls and shipment verification.
• Ensure compliance with FDA, EMA, ICH, and other global regulatory requirements.
• Lead and support internal and regulatory audits, inspections, and customer audits.
• Review batch data, deviations, and quality systems to determine product disposition.

Skills

Quality leadership

GMP compliance

Cross-functional teamwork

Aseptic processing

Regulatory knowledge

Education

Bachelor's degree in science

Job description

ProKidney in Winston-Salem, North Carolina, seeks a Senior Director, Quality Operations to provide strategic and operational leadership across GMP Quality Assurance for clinical and commercial drug product manufacturing. This role ensures robust quality systems, data integrity, and readiness across manufacturing, QC, and distribution.

You will partner with Manufacturing and Regulatory to maintain inspection readiness, drive CAPA, and support Phase III IND manufacturing through commercial