Global Quality Lead, Pharma Development & Compliance

Genentech; South San Francisco (CA); On-site; USD 111,000 - 206,000; Full time

Job summary

Genentech, based in South San Francisco, CA, seeks a Quality Lead in PDQ to shape quality assurance strategies across development and post-approval products, in a global matrix environment.

You will drive CtQ framework, audits, and inspections readiness with stakeholders worldwide; strong data analytics and regulatory knowledge required.

This role offers competitive salary and benefits; relocation not available.

Qualifications

• Bachelor's degree in a scientific or quality-related field, or equivalent experience.
• Experience in pharmaceutical, biotech, or medical device industries.
• Solid knowledge of global GxP regulations and quality roles (GCP, GVP, IVD/MD).
• Strong data and digital literacy with audit management and analytics tools.
• Proven critical thinking and project management skills to navigate ambiguity.

Responsibilities

• Drive risk-based Quality Assurance strategies and conclusions using CtQ framework.
• Plan, perform and lead audits and aggregate issues into trends for regulatory needs.
• Partner with stakeholders and present observations and compliance risks.
• Support regulatory inspections preparation and management.
• Contribute to PDQ process improvements and departmental goals.
• Maintain deep awareness of FDA, EU, ICH guidance across GxP areas.

Skills

Analytical thinking

Communication

Cross-cultural collaboration

Stakeholder influence

Education

Bachelor's degree in science/quality field

Job description

Genentech, based in South San Francisco, CA, seeks a Quality Lead in PDQ to shape quality assurance strategies across development and post-approval products, in a global matrix environment.

You will drive CtQ framework, audits, and inspections readiness with stakeholders worldwide; strong data analytics and regulatory knowledge required.

This role offers competitive salary and benefits; relocation not available.