Quality Systems & Compliance Leader, Biotech

Allogene Therapeutics; South San Francisco (CA); Hybrid; USD 230,000 - 270,000; Full time

Benefits offered by this job

Annual performance bonus

Equity and Stock options

Health insurance

Paid time off and company holidays

Job summary

Allogene Therapeutics is seeking a Senior Director of Quality Systems and Compliance to craft and execute global quality policies and compliance for clinical development and commercialization.

Based in South San Francisco with up to two remote days weekly, this leader will mature QMS, drive inspection readiness, and partner with Manufacturing, Regulatory, and Clinical QA to ensure patient safety and regulatory readiness.

Qualifications

• Extensive experience in pharma/biotech quality systems and compliance.
• Experience leading regulatory inspections (FDA/EMA) is required.
• Strong interpersonal and communication skills for senior management.

Responsibilities

• Lead the Quality Management System and ensure compliance with cGMP and regulatory standards.
• Collaborate with Manufacturing, Regulatory, and Clinical Quality Assurance to align policies and strategy.
• Promote a culture of quality, ownership, accountability, collaboration, and risk management.
• Serve as the lead for inspection readiness activities, supplier audits, regulatory inspections, and health authority interactions.
• Lead compliance risk management assessments and remediation of findings and CAPA.
• Oversee supplier quality regulatory compliance and risk management programs.
• Define and oversee initiatives to mature quality systems toward readiness for product commercialization.
• Advance digital solutions and continuous improvement to strengthen quality performance.
• Develop, monitor, and communicate quality metrics and KPIs to leadership.
• Build, coach, and develop a high-performing team.

Skills

Quality leadership

Regulatory affairs

Inspection readiness

Cross-functional collaboration

Team management

Education

B.S. in Biological Sciences, Chemistry, or Engineering

Advanced degree preferred

Job description

Allogene Therapeutics is seeking a Senior Director of Quality Systems and Compliance to craft and execute global quality policies and compliance for clinical development and commercialization.

Based in South San Francisco with up to two remote days weekly, this leader will mature QMS, drive inspection readiness, and partner with Manufacturing, Regulatory, and Clinical QA to ensure patient safety and regulatory readiness.