{"id":210990,"url":"https://alion.io/job/prokidney-sr-director-quality-operations","title":"Sr. Director, Quality Operations","company":{"id":7427,"name":"ProKidney","domain":"prokidney.com","url":"https://alion.io/company/prokidney","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"head","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Winston-Salem, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":114000,"max_usd":226000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":668},"experience_years_min":10,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-02-02T17:27:37Z","employer_posted_date":"2026-09-01","last_verified_at":"2026-11-01T10:47:17Z","board_verified":true,"closed_at":null,"days_open":271,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":271},"description":"Position Summary \nThe 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 ProKidney’s long-term quality operations capabilities.\nBeyond 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.\nThe 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.\nResponsibilities\n 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.\nOversee Quality Control laboratories, ensuring analytical readiness, method compliance, data governance, and timely testing to support production and release.\nDirect QA oversight of Warehouse, Materials, and Distribution, including incoming material qualification, storage conditions, inventory controls, sampling, dispensing, and shipment verification.\nEnsure compliance with FDA, EMA, ICH, and other global regulatory requirements.\nLead and support internal and external audits, regulatory inspections, and customer audits.\nResponsible 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.\nServe as the Quality lead to support product Risk Assessments, supporting the identification of Quality risks and appropriate mitigation plans to achieve compliant solutions.\nNon-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.\nProvide leadership to both Quality and Manufacturing staff by directing, mentoring, coaching and developing them towards professional growth, enhanced job performance and career satisfaction.\nProvide input for continuous improvement company quality systems related to GMP manufacturing.\nIdentify product quality issues/discrepancies, and effectively and proactively resolve them in a diplomatic, flexible and constructive manner.\nPerform risk assessments of new programs for entry into the GMP\nLead and manage complex projects/teams within corporate objectives and project timelines and participates in cross-functional projects in Quality expert and leader role.\nProvide strategies to address GMP manufacturing compliance gaps or determine enhancements to cross-functional quality systems.\nEnsures quality staff assesses and approves change controls associated with GMP manufacturing.\nBuild collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality assurance, regulatory, etc. at all levels.\nOperate as a role model establishing, educating, and enforcing standard operating procedures required for GMP compliance.\nLead investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions related to GMP manufacturing\nIdentify performance or compliance gaps and implement or propose solutions; solve complex problems of a technical nature.\nManage complexities within a product development environment to plan, organize, execute, monitor staff assignments and all activities necessary to achieve continuous clinical supply.\nQualifications\nBachelor’s 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.\nExtensive GMP operational experience overseeing investigational drug manufacturing and aseptic processing within GMP facilities.\nDemonstrated Quality leadership with a strong partnership approach to Manufacturing, ensuring compliant, high-quality product supply to patients.\nProven ability to build, lead, and develop high-performing GMP Quality Assurance teams.\nDeep knowledge of GMP, FDA, and EMA regulatory requirements for biologics, including cell, gene, and viral therapy products.\nStrong awareness of industry trends and the ability to apply emerging technologies and best practices to Quality Operations.\nWorking knowledge of aseptic techniques, cleanroom design and operation, and auditing methodologies.\nStrong leadership presence with the ability to excel in a fast-paced, high-throughput environment.\nDemonstrated ability to lead and manage cross-functional teams and projects in alignment with corporate objectives and timelines.\nSuccessful track record in mentoring and developing people managers.\nStrength in collaboration, teamwork, and constructive conflict management, fostering effective partnerships across functions.\nThe position reports directly to the VP, GMP Quality Assurance\n\nProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.\nApplicants must be eligible to work in the United States without the need for work visa or residency 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