Senior Director, Quality

The posting, as Tr1X wrote it

About Tr1X

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 www.tr1x.bio .

Position Summary

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.

Key Responsibilities

• 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

[…]
empowered to make a meaningful impact. We envision a world where autoimmune diseases are not just being treated but are cured.

Base Pay Range Anticipated: $240,000 – $270,000

Tr1X considers a variety of factors to determine salary such as education, years of experience, time in the position level, training, knowledge, skills, geographic location, and the market value of the position.

Compensation and Benefits

Tr1X provides a fair and competitive total rewards program that includes base salary; discretionary annual target bonus; incentive stock options; 401(k) retirement plan with company contribution; health and welfare insurance plans for employees (and their families) that include medical, dental, vision, long-term and short-term disability, and life insurance; paid time off (PTO); and paid holidays.

Tr1X embraces a diverse, open, and inclusive environment and believes a strong culture connection is key to success. Tr1X is committed to fairness in recruitment, hiring, transfer, promotion or any other employment practice without regard to race, color, citizenship, national origin, ancestry, religion, sex, pregnancy, marital status, sexual orientation, gender, gender identity and expression, age, physical and medical disability, medical condition, genetic information, political affiliation, protected veteran status, or any other characteristic protected by law. If you are an individual needing assistance to complete an employment application or would like to request an accommodation, please contact the Human Resources department at careers@tr1x.bio.

Notice to Employment Agencies

The Tr1X talent acquisition program is managed through internal resources, and unsolicited referrals and resumes are not accepted from employment agencies, unless advance written authorization is granted from the human resources department. Tr1X shall not be liable for any fees arising from any unsolicited or unauthorized candidate information received relative to position vacancies.