Sr. Director, Quality Operations at PROKIDNEY – Winston-Salem, North Carolina

Position Summary

The Senior Director, Quality Operations is responsible for providing strategic and operational leadership across all aspects of GMP Quality Assurance for the production of ProKidney drug products, both clinical and commercial, across all manufacturing sites. This role serves as a key quality leader and individual contributor in establishing, strengthening, and sustaining ProKidneys longterm quality operations capabilities.

Beyond batch release and disposition, the position provides comprehensive quality oversight for Manufacturing (Quality on the Floor), Quality Control, and Warehouse/Materials/Distribution operations to ensure consistent compliance and product readiness.

The Senior Director must ensure that robust quality systems, processes, and controls are in place to support Phase III investigational new drug (IND) manufacturing of investigational medicinal products including its transition to commercial. This includes ensuring alignment with global regulatory requirements, maintaining continuous inspection readiness, and supporting uninterrupted clinical supply and delivery commitments as ProKidney progresses toward commercialization.

Responsibilities

• Provide strategic quality oversight of Manufacturing Operations through a strong QualityontheFloor presence, ensuring adherence to cGMPs, data integrity, and batch record accuracy.
• Oversee Quality Control laboratories, ensuring analytical readiness, method compliance, data governance, and timely testing to support production and release.
• Direct QA oversight of Warehouse, Materials, and Distribution, including incoming material qualification, storage conditions, inventory controls, sampling, dispensing, 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.
• Responsible for clinical/commercial batch Ensure review of batch data, including batch records, deviations, and other quality systems as applicable to determine acceptability of product disposition.
• Serve as the Quality lead to support product Risk Assessments, supporting the identification of Quality risks and appropriate mitigation plans to achieve compliant solutions.
• Non-conformance/CAPA Management support. Review and approve non-conformance reports specifically associated with GMP manufacturing Mentor investigators and approvers on the investigation process and technical writing.
• Provide leadership to both Quality and Manufacturing staff by directing, mentoring, coaching and developing them towards professional growth, enhanced job performance and career satisfaction.
• Provide input for continuous improvement company quality systems related to GMP manufacturing.
• Identify product quality issues/discrepancies, and effectively and proactively resolve them in a diplomatic, flexible and constructive manner.
• Perform risk assessments of new programs for entry into the GMP
• Lead and manage complex projects/teams within corporate objectives and project timelines and participates in cross-functional projects in Quality expert and leader role.
• Provide strategies to address GMP manufacturing compliance gaps or determine enhancements to cross-functional quality systems.
• Ensures quality staff assesses and approves change controls associated with GMP manufacturing.
• Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality assurance, regulatory, etc. at all levels.
• Operate as a role model establishing, educating, and enforcing standard operating procedures required for GMP compliance.
• Lead investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions related to GMP manufacturing
• Identify performance or compliance gaps and implement or propose solutions; solve complex problems of a technical nature.
• Manage complexities within a product development environment to plan, organize, execute, monitor staff assignments and all activities necessary to achieve continuous clinical supply.

Qualifications

• Bachelors degree in a scientific or allied health field with 10+ years of Sterile manufacturing work experience on the quality side, or relevant comparable background in Biologics or Cell and Gene Therapy Manufacturing.
• Extensive GMP operational experience overseeing investigational drug manufacturing and aseptic processing within GMP facilities.
• Demonstrated Quality leadership with a strong partnership approach to Manufacturing, ensuring compliant, highquality product supply to patients.
• Proven ability to build, lead, and develop highperforming GMP Quality Assurance teams.
• Deep knowledge of GMP, FDA, and EMA regulatory requirements for biologics, including cell, gene, and viral therapy products.
• Strong awareness of industry trends and the ability to apply emerging technologies and best practices to Quality Operations.
• Working knowledge of aseptic techniques, cleanroom design and operation, and auditing methodologies.
• Strong leadership presence with the ability to excel in a fastpaced, highthroughput environment.
• Demonstrated ability to lead and manage crossfunctional teams and projects in alignment with corporate objectives and timelines.
• Successful track record in mentoring and developing people managers.
• Strength in collaboration, teamwork, and constructive conflict management, fostering effective partnerships across functions.

The position reports directly to the VP, GMP Quality Assurance