GCP Quality Strategy Lead for Clinical Trials & Inspections

Denali Therapeutics Inc; South San Francisco (CA); Remote; USD 171,000 - 223,000; Full time

Benefits offered by this job

401k

Healthcare coverage

ESPP

Broad range of other benefits

Job summary

Denali Therapeutics Inc. is seeking a senior GCP Quality lead to deliver strategic quality oversight across the clinical trial portfolio in the South San Francisco area.

The role anchors inspection readiness, risk-based decision making, and continuous improvement of the GCP Quality Management System. You will shape the evolution of Denali's quality systems, lead complex compliance matters, and collaborate with study teams, site leadership, and external partners to ensure patient safety and

Qualifications

• 12+ years of related experience with a Bachelor's degree.
• Experience developing or improving Quality Management Systems.
• Working knowledge of ICH E6 GCP guidelines, FDA CFR, and other global regs.
• Experience supporting regulatory inspections (FDA/EMA/MHRA or others).
• Experience providing quality oversight of CROs, vendors, labs and other outsourced services.
• Ability to influence cross-functional teams and lead strategic quality initiatives.

Responsibilities

• Lead GCP quality strategy across Study Execution Teams (SETs).
• Partner with Site Lead and cross-functional leaders to drive quality maturity.
• Lead proactive quality risk assessments and mitigation strategies.
• Own risk-based monitoring and analysis of quality issues; align with ICH-GCP and global regs.
• Lead Sponsor inspection strategy and regulatory interactions.
• Identify gaps, conduct root cause analysis, drive CAPA resolution.
• Oversee CAPA implementation and continuous improvement activities.
• Lead oversight of CROs and clinical vendors.
• Design and improve GCP Quality Systems, SOPs, and broader QMS.
• Develop inspection strategy documents, study storyboards, and readiness tools.
• QA review essential clinical trial documents and implement internal QA processes.

Skills

Quality management systems

ICH E6 GCP

Regulatory inspections

Vendor oversight

Cross-functional leadership

Executive communication

Education

Bachelor's degree required

Job description

Denali Therapeutics Inc. is seeking a senior GCP Quality lead to deliver strategic quality oversight across the clinical trial portfolio in the South San Francisco area.

The role anchors inspection readiness, risk-based decision making, and continuous improvement of the GCP Quality Management System. You will shape the evolution of Denali's quality systems, lead complex compliance matters, and collaborate with study teams, site leadership, and external partners to ensure patient safety and