Sr. Director, Quality Operations

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 Pro Kidney 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 Pro Kidney’s long‑term 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 Pro Kidney progresses toward commercialization.

• Provide strategic quality oversight of Manufacturing Operations through a strong Quality‑on‑the‑Floor 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…