GCP Quality Strategy & Inspection Lead

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

Benefits offered by this job

401k

Healthcare coverage

ESPP

Broad range of benefits

Job summary

Denali Therapeutics in South San Francisco seeks a seasoned GCP Quality Leader to oversee the global clinical trial portfolio, anchor inspection readiness, and drive continuous improvement of the GCP Quality Management System.

You will lead quality risk management, sponsor inspections, oversight of CROs and vendors, and shape scalable quality processes across development stages, ensuring compliance, ethics, and patient safety.

Qualifications

• 12+ years of related experience with a Bachelor's degree, or equivalent.
• Experience building, implementing, or improving Quality Management Systems.
• Working knowledge of ICH E6 GCP guidelines, FDA CFR, and global regulations.
• Demonstrated experience supporting or leading regulatory inspections (FDA, EMA, MHRA or other authorities).
• Experience providing quality oversight of CROs, vendors, labs and outsourced services.

Responsibilities

• Lead GCP quality strategy for assigned Study Execution Teams.
• Partner with site leadership and cross-functional teams to mature site-level quality.
• Lead proactive quality risk assessments and mitigation strategies.
• Own risk-based monitoring and analysis of quality issues with strong regulatory alignment.
• Lead Sponsor inspection strategy and inspection management.
• Identify gaps, conduct root cause analyses, and drive CAPA effectiveness.
• Oversee CAPA implementation and continuous improvement activities.
• Lead QA oversight of CROs and vendors across development lifecycle.
• Design and improve GCP QA processes, SOPs, and quality systems.

Skills

GCP quality oversight

Regulatory inspections

QMS implementation

ICH GCP knowledge

Cross-functional leadership

Vendor oversight

Quality risk management

Education

Bachelor's degree

Tools

GCP QA tools

Job description

Denali Therapeutics in South San Francisco seeks a seasoned GCP Quality Leader to oversee the global clinical trial portfolio, anchor inspection readiness, and drive continuous improvement of the GCP Quality Management System.

You will lead quality risk management, sponsor inspections, oversight of CROs and vendors, and shape scalable quality processes across development stages, ensuring compliance, ethics, and patient safety.