Senior GCP Quality Partner – Early Clinical Development

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

Benefits offered by this job

Hybrid work model

On-campus 3 days/week

Job summary

Genentech is seeking a Quality Partner within Early Clinical Development (ECD) Quality to champion a proactive, risk-based quality culture and ensure safe, efficient progression to patients. You will act as the primary GCP quality advisor to study teams and external partners, embedding quality by design across cutting-edge programs.

You will translate regulatory requirements into actionable guidance, lead CAPA efforts, and collaborate across global teams to maintain data integrity and trial

Qualifications

• Bachelor’s degree in life science or related field; advanced degrees welcomed.
• 5–8 years in pharmaceutical drug development; minimum 6 years in GCP/QA.
• Solid knowledge of GCP, ICH guidelines, and global regulatory frameworks.
• Strong analytical and problem-solving skills with risk assessment ability.
• Proven cross-functional collaboration and stakeholder management.

Responsibilities

• Provide expert GCP quality guidance and risk-mitigation strategies.
• Partner with Early Clinical Development and external vendors on compliance.
• Lead quality reviews, CAPA planning, and root-cause analyses.
• Support QMS activities, document control, and process alignment.
• Deliver clear compliance communications and targeted training.

Skills

GCP knowledge

Regulatory compliance

Analytical thinking

Cross-functional collaboration

Stakeholder management

Education

Bachelor’s degree in life science

MS/PhD welcomed

Tools

QMS experience

Job description

Genentech is seeking a Quality Partner within Early Clinical Development (ECD) Quality to champion a proactive, risk-based quality culture and ensure safe, efficient progression to patients. You will act as the primary GCP quality advisor to study teams and external partners, embedding quality by design across cutting-edge programs.

You will translate regulatory requirements into actionable guidance, lead CAPA efforts, and collaborate across global teams to maintain data integrity and trial