Senior GCP Quality Leader for Early Clinical Development

Genentech; South San Francisco (CA); Hybrid; USD 141,000 - 262,000; Full time

Job summary

Genentech seeks a Quality Partner within Early Clinical Development (ECD) Quality to champion a proactive, risk-based quality culture ensuring safe and efficient movement of innovative science to patients.

You will serve as the primary GCP quality advisor to trial teams and external partners, embedding quality by design across cutting-edge programs and resolving compliance challenges before timelines or regulatory integrity are affected.

Qualifications

• Strong knowledge of GCP, ICH guidelines and global regulatory frameworks.
• Experience identifying compliance risks and implementing CAPA solutions.
• Ability to translate regulatory requirements into actionable guidance.

Responsibilities

• Provide expert GCP quality guidance and risk-mitigation strategies for early trials.
• Partner with ECD and external vendors to enable compliant trial conduct.
• Lead quality management system activities and document control.
• Deliver compliance communications and targeted training.
• Support root cause analyses and CAPA plan development.

Skills

GCP knowledge

ICH guidelines

CAPA planning

Cross-functional collaboration

Stakeholder management

Education

Bachelor's degree in life science

Job description

Genentech seeks a Quality Partner within Early Clinical Development (ECD) Quality to champion a proactive, risk-based quality culture ensuring safe and efficient movement of innovative science to patients.

You will serve as the primary GCP quality advisor to trial teams and external partners, embedding quality by design across cutting-edge programs and resolving compliance challenges before timelines or regulatory integrity are affected.