Senior Director, Quality & Compliance (Biotech)

Tr1X, Inc.; San Diego (CA); On-site; USD 240,000 - 270,000; Full time

Benefits offered by this job

Discretionary annual target bonus

Stock options

401(k) with company contribution

Health, dental, vision insurance

PTO and paid holidays

Job summary

Tr1X, Inc. is seeking a Senior Director of Quality in San Diego to lead the global quality organization, oversee GxP programs, and ensure product integrity and patient safety.

The role drives development, implementation, and continuous improvement of quality systems across clinical and manufacturing operations. The SD will maintain regulatory compliance, manage audits, and collaborate with CROs and internal teams while shaping the department's budget and strategic plans for long-term quality

Qualifications

• B.S. in scientific discipline (life sciences preferred).
• 12+ years in pharma/biotech at FDA-regulated sites within quality operations.
• 5+ years in leadership with at least 3 years supervising quality professionals.
• Biologics/cellular therapy manufacturing experience.
• Experience hosting regulatory inspections and presenting quality programs.
• Advanced knowledge of FDA/ICH regulations, GxP systems, and operational excellence.
• Knowledge of GCP/CQA; strong budgeting and forecasting ability.

Responsibilities

• Provide oversight of quality risks and report risks to senior stakeholders.
• Manage a global audit program for vendor/supplier performance and compliance.
• Maintain quality management system governance for GxP data.
• Ensure compliance with FDA, EMA, ICH guidelines.
• Lead and mentor quality teams; align with company goals.
• Drive continuous improvement of quality processes and systems.
• Collaborate with clinical operations, CROs, and clinical staff to ensure GCP compliance.
• Monitor quality metrics and KPIs; identify trends and improvement areas.
• Integrate quality considerations into product development, manufacturing, and distribution.

Skills

Quality leadership

Regulatory compliance

Strategic planning

Communication

Project management

Quality systems

Audits

Education

B.S. in life sciences

Tools

MS Office

QMS software

Job description

Tr1X, Inc. is seeking a Senior Director of Quality in San Diego to lead the global quality organization, oversee GxP programs, and ensure product integrity and patient safety.

The role drives development, implementation, and continuous improvement of quality systems across clinical and manufacturing operations. The SD will maintain regulatory compliance, manage audits, and collaborate with CROs and internal teams while shaping the department's budget and strategic plans for long-term quality