Senior Director, Quality

About Tr1X

Tr1X is a clinical-stage biotech company focused on developing engineered Tr1 cell therapies aimed at restoring immune balance in autoimmune and inflammatory disorders. Utilizing the unique properties of Tr1 cells, Tr1X is advancing a portfolio including off-the-shelf allogeneic and in vivo CAR-Tr1 therapies targeting immune dysfunction-driven diseases such as transplant-related complications. Founded by pioneers of Tr1 cell discovery, the company is dedicated to creating lasting, potentially curative therapeutics for high unmet medical needs.

Position Summary

The Senior Director of Quality will lead the entire quality organization, overseeing all internal and external GxP operations including clinical quality assurance. This role is accountable for establishing a strong quality culture and managing the development, implementation, and ongoing enhancement of quality systems to ensure compliance with regulatory standards. The Senior Director is responsible for critical decisions impacting product integrity, patient safety, regulatory adherence, and business continuity. The position involves collaboration with multiple stakeholders, leading a team across quality systems, control, assurance, clinical quality, and compliance functions.

Key Responsibilities

• Lead oversight of quality risk management and communicate risks to senior leadership.
• Administer a comprehensive global audit program to monitor vendor and supplier compliance, including delivering analytics and reports.
• Maintain and govern the quality management system for GxP data control and storage.
• Ensure full compliance with regulatory agencies such as FDA, EMA, and align with ICH guidelines.
• Offer strategic guidance aligning quality initiatives with overall corporate objectives.
• Drive continuous improvements to increase quality process efficiency and effectiveness.
• Represent Tr1X in regulatory interactions and maintain robust external partnerships.
• Collaborate with clinical teams and CROs to ensure GCP compliance during clinical trials.
• Monitor and analyze quality performance metrics to identify trends and improvement areas.
• Work cross-functionally to integrate quality into development, manufacturing, distribution, and clinical study activities.
• Conduct routine audits and inspections to detect compliance gaps and risks.
• Promote a culture of quality and compliance via training, communication, and recognition initiatives.
• Remain updated on industry trends and recommend new quality technologies and methodologies.
• Lead, mentor, and develop the quality team, providing clear guidance and growth opportunities.

Required Qualifications & Experience

• Bachelor's degree in a scientific field such as pharmaceuticals or biologics.
• At least 12 years in pharmaceutical or biotech quality operations at FDA-regulated manufacturing sites.
• Minimum 5 years leadership experience in quality, including 3 years supervising technical or quality personnel.
• Experience specifically in biologics or cellular therapy manufacturing.
• Skilled in managing regulatory inspections and presenting compliance programs to agency reviewers.
• Strong knowledge of FDA/ICH regulations, GxP quality systems, and operational excellence for cellular therapeutics production.
• Working familiarity with GCP and clinical quality assurance.
• Ability to plan long-term projects with clear timelines and budget management.
• Effective multitasking and prioritization under deadline pressure, delivering results.
• Excellent communication, organizational, and time-management skills.
• Proficient in Microsoft Office applications.

Additional Requirements

• Must be legally authorized to work in the U.S.
• Position requires on-site presence in San Diego, CA.

Compensation and Benefits

Anticipated base salary range is $225,000 to $260,000, determined by factors including education, experience, knowledge, skills, position tenure, and geography. Benefits include discretionary annual bonus, stock options, 401(k) with company match, medical/dental/vision insurance, disability and life coverage, paid time off, and holidays.

About Working at Tr1X

Tr1X is driven by a mission to deliver transformative patient therapies through scientific innovation and collaboration. The company fosters a culture of excellence, positivity, and agility while prioritizing patient impact. Tr1X promotes diversity and inclusion and supports employee engagement and empowerment.

Employment Agencies

Tr1X manages talent acquisition internally and does not accept unsolicited agency referrals without prior authorization. The company is not liable for fees related to unauthorized candidate submissions.