Senior Quality Lead: Strategy, Audits & Regulatory Readiness

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

Job summary

Genentech is seeking an experienced Senior Quality Lead to join the Quality Assurance Programs team in South San Francisco, CA. You will design and deliver quality strategies for molecules, lead audits, and manage regulatory inspections with a risk-based CtQ framework.

Responsibilities include independent issue management, stakeholder communication, and mentoring junior leads. Strong knowledge of GCP/GVP and device/CSV is preferred; relocation is not offered, onsite presence is prioritized.

Qualifications

• Bachelor’s degree or equivalent in scientific or quality-related field; advanced degree preferred.
• Demonstrated knowledge of clinical/pharmacovigilance/regulatory requirements.
• Project management experience with leadership, mentoring and coaching; ability to organize and execute tasks.
• High degree of experience leading multiple audits in GCP areas.

Responsibilities

• Designs and delivers Quality Strategies for assigned Molecules using a risk-based CtQ framework and strong stakeholder partnerships.
• Define and lead audits, develop methodology, and manage end-to-end audit processes.
• Independently manage complex quality issues and elevate significant ones to PDQ management.
• Draw conclusions on Quality Positions and present observations to stakeholders and Regulatory teams.
• Contribute to PDQ goals and drive adoption of PDQ processes and SOPs.

Skills

Project management

Leadership

Mentoring & coaching

Audits (GCP)

Data literacy

Communication

Multilingual / cross-cultural

Education

Bachelor's degree in scientific/quality field

Advanced degree preferred

Tools

CSV experience

QA data analytics tools

Job description

Genentech is seeking an experienced Senior Quality Lead to join the Quality Assurance Programs team in South San Francisco, CA. You will design and deliver quality strategies for molecules, lead audits, and manage regulatory inspections with a risk-based CtQ framework.

Responsibilities include independent issue management, stakeholder communication, and mentoring junior leads. Strong knowledge of GCP/GVP and device/CSV is preferred; relocation is not offered, onsite presence is prioritized.