Senior Quality Lead - Remote QA Strategy & Audits

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

Benefits offered by this job

Discretionary annual bonus

Comprehensive benefits

Job summary

Genentech is seeking an experienced Senior Quality Lead in South San Francisco, CA. You will shape QA strategies, lead audits, and manage regulatory inspections for post-approval products, leveraging GCP, GVP, and device/C SV knowledge.

Responsibilities include designing risk-based QA approaches, leading data-driven audits, and mentoring junior leads within a global, matrixed team. Onsite presence is preferred with a possible remote option.

Qualifications

• Bachelor’s degree in a scientific or quality field is required with advanced degrees preferred.
• Strong knowledge of clinical/pharmacovigilance regulatory requirements and risk-based QA strategies.
• Proven leadership in handling multiple audits across GCP domains and complex inspections.
• Experience mentoring Quality Leads and collaborating with global stakeholders.

Responsibilities

• Designs and delivers Quality Strategies and conclusions using CtQ framework and risk-based methods.
• Define, lead, and execute audits, including data analytics and reporting outcomes.
• Independently manage complex quality issues and drive process improvements across molecules.
• Lead stakeholder communications and present findings to Legal, Regulatory, and Pharma teams.
• Mentor Quality Leads and contribute to PDQ goals and process development.

Skills

GCP/GVP regulations

Project management

Audit leadership

Mentoring & coaching

Data literacy

Education

Bachelor’s degree or equivalent in scientific or quality-related field

Advanced degree preferred

Job description

Genentech is seeking an experienced Senior Quality Lead in South San Francisco, CA. You will shape QA strategies, lead audits, and manage regulatory inspections for post-approval products, leveraging GCP, GVP, and device/C SV knowledge.

Responsibilities include designing risk-based QA approaches, leading data-driven audits, and mentoring junior leads within a global, matrixed team. Onsite presence is preferred with a possible remote option.