Quality Operations Executive — GMP Cell Therapy

Neurona Therapeutics; South San Francisco (CA); On-site; USD 180,000 - 260,000; Full time

Job summary

Neurona Therapeutics is hiring for a Director/Senior Director of Quality Operations in South San Francisco, CA. You will lead QA oversight across GMP Manufacturing, QC, and Supply Chain to ensure product quality and patient safety.

The role emphasizes risk-based decision making, regulatory readiness, and mentoring a team of quality professionals in a fast-paced cell therapy environment.

Qualifications

• Minimum 10 years of Quality experience in a GMP-regulated environment.
• Hands-on GMP Manufacturing and QC operations experience.
• Strong knowledge of EU GMP, ICH, FDA guidance.
• Proven leadership in batch disposition, investigations, CAPA, and change management.
• Experience with Health Canada or FDA inspections is beneficial.
• BA/BS in Microbiology, Biology, Chemistry with 10+ years quality experience.

Responsibilities

• Provide QA oversight of GMP Manufacturing, QC, Operations, and Supply Chain.
• Apply Quality Risk Management to manufacturing, QC, Operations, and Supply Chain.
• Partner with cross-functional teams to identify and mitigate quality risks.
• Review and approve batch records, deviations, investigations, and CAPA.
• Lead or support regulatory inspections and internal audits.
• Maintain data integrity and ALCOA++ compliance.

Skills

Quality leadership

Regulatory knowledge

Documentation

Communication

Problem solving

Data analysis

Training & mentoring

Cross-functional collaboration

GMP knowledge

Auditing

Education

BA/BS in Microbiology, Biology, Chemistry

Job description

Neurona Therapeutics is hiring for a Director/Senior Director of Quality Operations in South San Francisco, CA. You will lead QA oversight across GMP Manufacturing, QC, and Supply Chain to ensure product quality and patient safety.

The role emphasizes risk-based decision making, regulatory readiness, and mentoring a team of quality professionals in a fast-paced cell therapy environment.