ProKidney Corp. · 18 hours ago
Sr. Director, Quality Operations
Winston-Salem, North Carolina, United States
Full-time
Onsite
Director/Executive
10+ years expProKidney is a company focused on GMP Quality Assurance for drug production, and they are seeking a Senior Director of Quality Operations. This role is responsible for overseeing quality assurance processes, managing teams, and ensuring compliance with regulatory standards in the manufacturing of investigational medicinal products.
Health CareTherapeutics
No H1B
Responsibilities
Responsible for the QA Product Release team, the QA Material Release team, and the QA Validation team
Responsible for clinical batch Ensure review of batch data, including batch records, deviations, and other quality systems as applicable to determine acceptability of product disposition
Responsible for raw material release and disposition for all class of materials received at ProKidney for GMP purposes
Responsible for the QA review of all GMP equipment and Facilities upgrades that the QA Validation team performs for all GMP equipment and Facilities
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
Ensure compliance with current S. and EU cGMP regulations and industry standards
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 the management review of quality compliance and operational KPIs at the manufacturing facility; ensure timely mitigation of unfavorable trends
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
Establish, educate, and enforce standard operating procedures required under
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
Qualification
Required
Quality GMP operational experience implementing and overseeing investigational drug manufacture and aseptic processing operations in a manufacturing facility
Demonstrated Quality leadership through a partnership approach with manufacturing to enable high quality and compliant product distribution to patients is required
Demonstrated experience building and leading exceptional GMP Quality Assurance teams
Knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products
Strong knowledge of current industry trends and the ability to use the latest
Working knowledge of aseptic practices and clean room design/operations, auditing techniques
Strong leadership skills with the ability to thrive in a high throughput
Ability to lead and manage projects/teams within corporate objectives and project
Successful in mentoring people
Collaboration / Teamwork / Conflict Management
Bachelor's degree in a scientific or allied health field with 10+ years of relevant work experience, or relevant comparable background in Biologics or Cell and Gene Therapy Manufacturing
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship
Preferred
Biologic or cell therapy manufacturing and/or analytical
A combination of experiences in quality assurance plus operations, laboratory, or related functional roles. Example functional roles include quality assurance of GMP operations, quality engineering, manufacturing, process engineering, product development, process development, materials management, supply chain management, quality control, analytical development, CMC regulatory affairs, equipment, or facilities management
Diverse experiences in a GMP environment including but not limited to batch production record development, review, or approval, ancillary batch related records, standard operating procedures, work instructions, raw materials, deviations, change control, corrective actions, preventive actions, out of specification results, validation plans or protocols, equipment qualification, audits, electronic inventory systems, quality management systems
Ability to identify, focus, and solve problems in a timely and efficient
Experience with quality audits and EU regulatory
Experience or working knowledge of R&D or clinical supply areas
Company
ProKidney Corp.
ProKidney, a pioneer in the treatment of chronic kidney disease through innovations in cellular therapy, was founded in 2015 after a decade of research.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$345MKey Investors
Social Capital
2024-06-11Post Ipo Equity· $140M
2022-07-12Post Ipo Equity· $205M
2022-07-12IPO
Leadership Team
Bruce Culleton
Chief Executive Officer
Recent News
2026-01-06
2026-01-03
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