Senior Director, Quality

Tr1X is a clinical-stage biotechnology company developing engineered Tr1 cell therapies to restore immune balance in autoimmune and inflammatory diseases. Leveraging the unique biology of Tr1 cells, the company is advancing a pipeline of off-the-shelf allogeneic and in vivo CAR-Tr1 therapies designed to deliver targeted immunoregulation and address diseases driven by immune dysfunction, including transplant-related complications. Founded by pioneers in the discovery of Tr1 cells, Tr1X, Inc.

is focused on developing durable, potentially curative therapies for conditions with high unmet need. For more information, visit (Use the "Apply for this Job" box below). .

The Senior Director, Quality (SD) reports to the Chief Technical Officer and is responsible for all aspects of the quality organization including support and oversight for all internal and external GxP operations inclusive of clinical quality assurance (CQA). As the leader of the quality function, the SD establishes and maintains a culture of quality across the organization and is responsible for overseeing development, implementation, and continuous improvement of all quality systems to ensure that all products, processes, and operations comply with applicable regulatory requirements.

The SD is ultimately responsible and accountable for critical decisions that directly impact product integrity, patient safety, regulatory compliance, and business continuing. The SD works with both internal and external stakeholders to manage timelines, meet internal deliverables and develop a best-in-class quality organization. This position develops, leads, and coaches the teams responsible for quality systems, quality control, document control, quality assurance, clinical quality, and compliance.

The SD responsibilities include implementation and continuous improvement of policies, procedures and standards necessary to ensure compliance with applicable GxPs. Additional responsibilities include team building, career development, assisting with financial reviews, establishment of annual budgets and identification and rollout of yearly goals and objectives and longer-term strategic plans for the department.

• Provide oversight of quality risks and report risks to senior stakeholders.
• Manage a global audit program to ensure vendor/supplier performance and compliance, including development and presentation of meaningful metrics and summaries.
• Oversee maintenance of quality management system that collects, stores, establishes control and provides governance for the use of GxP data.
• Ensure compliance with all regulatory requirements and industry standards, including FDA, EMA, and ICH guidelines.
• Provide strategic direction and guidance to the quality team, ensuring alignment with company objectives and goals.
• Drive continuous improvement initiatives to enhance the efficiency and effectiveness of quality processes and systems.
• Represent the company in interactions and maintain strong relationships with regulatory agencies, external partners, industry groups, and internal stakeholders.
• Partner with clinical operations, CROs, and other key clinical staff to ensure clinical trials are conducted per GCP guidelines.
• Monitor and assess quality metrics and KPIs to identify trends and areas for improvement.
• Collaborate with cross-functional teams to ensure quality considerations are integrated into all aspects of product development, manufacturing, distribution, and clinical study design/execution.
• Conduct regular audits and inspections to assess compliance and identify potential risks and areas for improvement.
• Foster a culture of quality and compliance throughout the organization through training, communication, and recognition programs.
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