Director, Clinical Risk & Quality Assurance

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

Benefits offered by this job

401k plan

Healthcare coverage

ESPP

Job summary

Denali Therapeutics, located in South San Francisco, seeks an Associate Director, Risk Management to lead GCP risk management across clinical development. You will partner with Quality colleagues and cross‑functional teams to identify, assess, and mitigate quality risks and drive risk‑based decision making across programs.

Focused on leading CAPA, deviations, vendor qualification, and QMS improvements, you will help ensure inspection readiness and robust regulatory compliance across Denali's

Qualifications

• Bachelor's degree with 12+ years of GCP QA experience or equivalent.
• Master's degree with 10+ years or PhD with 7+ years.
• Experience applying ICH E6 GCP, GVP, and FDA regulations.

Responsibilities

• Lead the GCP deviation and CAPA processes, ensuring timely investigation, implementation, effectiveness verification, and closure.
• Partner with study teams to identify, assess, and mitigate quality risks across clinical development programs using Quality by Design and risk-based quality management principles.
• Serve as the subject matter expert on GCP quality risk management, providing guidance on detection, investigation, documentation, and resolution of GCP noncompliance.
• Maintain quality oversight of the Clinical Trial Risk Tracking Program and ensure risks are documented, monitored, and escalated.
• Review deviations, noncompliance, and quality events across development programs to identify systemic risks and drive continuous improvement.
• Lead GCP and GVP vendor qualification and ongoing quality oversight activities to ensure regulatory compliance.

Skills

GCP Quality Assurance

GxP regulatory knowledge

Quality by Design (QbD)

RBQM

Quality Management System (QMS)

Regulatory inspections readiness

Vendor qualification

Education

Bachelor's degree (related field)

Master's degree (related field)

PhD (related field)

Tools

QMS software

Job description

Denali Therapeutics, located in South San Francisco, seeks an Associate Director, Risk Management to lead GCP risk management across clinical development. You will partner with Quality colleagues and cross‑functional teams to identify, assess, and mitigate quality risks and drive risk‑based decision making across programs.

Focused on leading CAPA, deviations, vendor qualification, and QMS improvements, you will help ensure inspection readiness and robust regulatory compliance across Denali's