GMP Quality Operations Executive

ProKidney; White Settlement (TX); On-site; USD 220,000 - 300,000; Full time

Job summary

ProKidney Corp. seeks a Senior Director, Quality Operations to lead GMP Quality Assurance across clinical and commercial drug product manufacturing, spanning multiple sites.

This role drives data integrity, batch release, and continuous improvement while aligning with global regulatory standards. The successful candidate will oversee Manufacturing Quality-on-the-Floor, Quality Control, and Warehouse/Distribution, ensuring readiness for Phase III and eventual commercialization, and will mentor

Qualifications

• Bachelor's degree in science with 10+ years of sterile manufacturing quality experience.
• Extensive GMP experience overseeing investigational drug manufacturing and aseptic processing.
• Demonstrated quality leadership with a strong partnership approach to Manufacturing.
• Proven ability to build, lead, and develop GMP Quality Assurance teams.
• Deep knowledge of GMP, FDA, and EMA regulatory requirements for biologics, including cell, gene, and viral therapies.
• Awareness of industry trends and ability to apply emerging technologies to Quality Operations.
• Working knowledge of aseptic techniques, cleanroom design and operation, and auditing methodologies.
• Strong leadership presence to excel in fast-paced environments.
• Proven ability to lead cross-functional teams and projects aligned with corporate objectives.
• Mentoring and developing people managers; collaborative and constructive as a default.

Responsibilities

• Provide strategic quality oversight of Manufacturing Operations with Quality-on-the-Floor presence, ensuring cGMPs and batch record accuracy.
• Oversee Quality Control laboratories for analytical readiness, method compliance, and data governance.
• Direct QA oversight of Warehouse, Materials, and Distribution, including material qualification and shipment verification.
• Ensure compliance with FDA, EMA, ICH, and other global regulatory requirements.
• Lead and support internal and external audits, regulatory inspections, and customer audits.
• Review batch data, deviations, and quality systems to determine product disposition.
• Lead risk assessments and mitigations for GMP manufacturing programs.
• Manage CAPA processes and mentor investigators on investigation procedures.
• Provide leadership and development for Quality and Manufacturing staff; drive continuous improvement.
• Identify quality issues and implement effective solutions; manage complex projects to support continuous clinical supply.

Skills

Sterile manufacturing

GMP compliance

Quality leadership

Cross-functional teamwork

Mentoring & people management

Root cause analysis

Process improvement

Regulatory knowledge (FDA/EMA)

Education

Bachelor's degree in science

Job description

ProKidney Corp. seeks a Senior Director, Quality Operations to lead GMP Quality Assurance across clinical and commercial drug product manufacturing, spanning multiple sites.

This role drives data integrity, batch release, and continuous improvement while aligning with global regulatory standards. The successful candidate will oversee Manufacturing Quality-on-the-Floor, Quality Control, and Warehouse/Distribution, ensuring readiness for Phase III and eventual commercialization, and will mentor