Executive Director, GMP Quality Assurance

Artiva Biotherapeutics Inc.; San Diego (CA); On-site; USD 270,000 - 290,000; Full time

Job summary

Artiva Biotherapeutics Inc. in San Diego, CA, seeks an Executive Director of GMP Quality Assurance to lead internal GMP quality operations and ensure compliance with FDA/EMA. You will own QA systems, batch disposition, deviations, CAPA, change control, inspection readiness, and report to the VP of Quality.

The role demands 15+ years of GMP QA experience in biologics/ccell therapy with strong leadership and regulatory expertise, plus willingness to travel and work on-site in San Diego.

Qualifications

• 15+ years of progressive GMP QA experience in biologics, cell therapy, or pharma.
• 8+ years in a senior quality leadership role.
• Hands-on experience hosting FDA/health authority inspections.
• Expertise with 21 CFR Parts 210/211 and ICH guidelines.
• Track record building GMP QA operations in biotech.

Responsibilities

• Lead GMP Quality Assurance operations, including document control, training, and material release.
• Oversee deviations, CAPA, change control, and annual product reviews.
• Chair GMP governance meetings and lead inspection readiness activities.
• Ensure compliance with FDA/EMA and global health authorities.
• Prepare for BLA readiness and support regulatory submissions with QA data.
• Oversee technology transfer, validation, and lifecycle changes.
• Manage GMP QA risk register and drive risk-based decisions.
• Build and lead the QA team with supervision and development.

Skills

GMP QA leadership

Leadership

Regulatory inspections

Cross-functional collaboration

Risk management

Quality systems

Education

Bachelor’s degree in life sciences or related field

Advanced degree or certification (ASQ CQA, RAC) preferred

Job description

Artiva Biotherapeutics Inc. in San Diego, CA, seeks an Executive Director of GMP Quality Assurance to lead internal GMP quality operations and ensure compliance with FDA/EMA. You will own QA systems, batch disposition, deviations, CAPA, change control, inspection readiness, and report to the VP of Quality.

The role demands 15+ years of GMP QA experience in biologics/ccell therapy with strong leadership and regulatory expertise, plus willingness to travel and work on-site in San Diego.