Senior Quality & Compliance Leader, Early Clinical Dev

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

Job summary

Genentech seeks a Principal Clinical Quality Compliance and Policy Lead to partner with Early Clinical Development teams. You will translate global regulatory requirements into pragmatic compliance strategies that strengthen our early-stage trial programs.

You will drive strategic partnerships, provide expert GCP direction, lead global initiatives, and oversee QMS activities with CAPA and deviation management. Hybrid on-site work in South San Francisco.

Qualifications

• Bachelor's degree in life sciences or related field.
• 8+ years in GCP/ICH and regulatory / clinical quality assurance.
• Experience leading cross-functional quality initiatives.
• Ability to translate regulatory requirements into practical strategies.

Responsibilities

• Drive strategic partnerships across ECD and global stakeholders.
• Provide strategic quality direction and proactive risk mitigation.
• Lead global initiatives, working groups, and policy development.
• Oversee QMS activities including deviation management and CAPA.
• Direct Health Authority inspection readiness initiatives and SOP optimizations.
• Establish KQIs and compliance metrics to identify trends.
• Champion a robust culture of quality across early programs.
• Manage and lead a team with coaching and performance development.

Skills

Strategic leadership

GCP / ICH knowledge

Regulatory compliance

Stakeholder management

Influential communication

Education

Bachelor's degree in life sciences

Advanced degree preferred (MS/PhD/JD/MD)

Job description

Genentech seeks a Principal Clinical Quality Compliance and Policy Lead to partner with Early Clinical Development teams. You will translate global regulatory requirements into pragmatic compliance strategies that strengthen our early-stage trial programs.

You will drive strategic partnerships, provide expert GCP direction, lead global initiatives, and oversee QMS activities with CAPA and deviation management. Hybrid on-site work in South San Francisco.