Senior Global Clinical Quality & Compliance Leader

Genentech; San Francisco (CA); Hybrid; USD 175,000 - 325,000; Full time

Benefits offered by this job

Hybrid schedule 3 days on campus

Discretionary annual bonus

Job summary

Genentech in South San Francisco is seeking a Principal Clinical Quality Compliance and Policy Lead to embed with Early Clinical Development study teams and drive a proactive quality culture across the organization.

You will translate complex global regulatory requirements into pragmatic compliance strategies, provide GCP expertise, lead global initiatives, oversee QMS activities, drive inspection readiness, establish KQIs, and manage a team with coaching and strategic direction.

Qualifications

• Bachelor's degree in life sciences or related field.
• Minimum 8 years in a GCP/regulatory or clinical quality assurance role.
• Deep knowledge of GCP/ICH guidelines and health authority regulations.
• Proven strategic problem-solving and matrix leadership experience.
• Strong ability to distill complex regulations into actionable strategies.

Responsibilities

• Drive strategic partnerships across ECD and global stakeholders on compliance strategy.
• Provide strategic quality direction and proactive risk mitigation for early programs.
• Lead high‑impact global initiatives, working groups, and policy development.
• Oversee QMS activities including deviation management, root cause analyses, CAPA.
• Direct health authority inspection readiness initiatives and SOP optimization.
• Establish KPIs and compliance metrics to identify trends and drive improvement.
• Champion a robust culture of quality through targeted training and communications.
• Manage and lead a team with strategic direction and ongoing coaching.

Skills

GCP & regulatory leadership

Strategic problem solving

Matrix leadership

Influential communicator

Regulatory compliance

Education

Bachelor's degree in life sciences or related

Advanced degree (PhD/MD/JD)

Job description

Genentech in South San Francisco is seeking a Principal Clinical Quality Compliance and Policy Lead to embed with Early Clinical Development study teams and drive a proactive quality culture across the organization.

You will translate complex global regulatory requirements into pragmatic compliance strategies, provide GCP expertise, lead global initiatives, oversee QMS activities, drive inspection readiness, establish KQIs, and manage a team with coaching and strategic direction.