Associate Director, Clinical Quality (Remote Eligible)
Denali Therapeutics
August 25, 2026
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Key Accountabilities / Core Job Responsibilities:
- Lead GCP quality strategy on assigned Study Execution Teams (SETs).
- Partner with the Zurich Site Lead and cross-functional leaders to drive site-level quality maturity and operational excellence.
- Lead proactive quality risk assessments and drive risk mitigation throughout study execution.
- Own risk-based monitoring and analysis of quality issues; provide strategic guidance aligned with ICH-GCP and applicable global regulations.
- Lead Sponsor inspection strategy, inspection management, regulatory interactions, inspection responses, and CAPA effectiveness.
- Identify quality/compliance gaps, direct root cause analysis, drive CAPA development to resolution; oversee CAPA implementation, effectiveness reviews, and continuous improvement.
- Lead evaluation, selection, and ongoing quality oversight of CROs and clinical vendors.
- Design and continuously improve GCP Quality Systems, SOPs, and the Quality Management System.
- Develop inspection strategy documents, study storyboards, and inspection readiness tools.
- Own QA review of essential clinical trial documents; implement internal GCP QA processes and tools.
- Represent Clinical Quality Assurance in cross-functional initiatives and champion compliance, ethics, and patient safety.
Qualifications / Skills:
- Typically 12+ years related experience with a Bachelor’s degree (or equivalent combination).
- Experience developing/implementing/improving Quality Management Systems.
- Working knowledge of ICH E6 GCP, FDA CFR, and applicable global regulations.
- Experience supporting/leading regulatory inspections (FDA, EMA, MHRA, or others).
- Experience providing quality oversight of CROs, vendors, laboratories, and outsourced service providers.
- Ability to influence cross-functional teams in a matrix organization.
- Experience with ICH E6(R3) Quality by Design and Quality Risk Management.
- Excellent communication/presentation; ability to brief senior leadership and inspectors.
- Strong critical thinking to synthesize complex, ambiguous information to drive resolution.
- Lead GCP quality strategy on assigned Study Execution Teams (SETs).
- Partner with the Zurich Site Lead and cross-functional leaders to drive site-level quality maturity and operational excellence.
- Lead proactive quality risk assessments and drive risk mitigation throughout study execution.
- Own risk-based monitoring and analysis of quality issues; provide strategic guidance aligned with ICH-GCP and applicable global regulations.
- Lead Sponsor inspection strategy, inspection management, regulatory interactions, inspection responses, and CAPA effectiveness.
- Identify quality/compliance gaps, direct root cause analysis, drive CAPA development to resolution; oversee CAPA implementation, effectiveness reviews, and continuous improvement.
- Lead evaluation, selection, and ongoing quality oversight of CROs and clinical vendors.
- Design and continuously improve GCP Quality Systems, SOPs, and the Quality Management System.
- Develop inspection strategy documents, study storyboards, and inspection readiness tools.
- Own QA review of essential clinical trial documents; implement internal GCP QA processes and tools.
- Represent Clinical Quality Assurance in cross-functional initiatives and champion compliance, ethics, and patient safety.
Qualifications / Skills:
- Typically 12+ years related experience with a Bachelor’s degree (or equivalent combination).
- Experience developing/implementing/improving Quality Management Systems.
- Working knowledge of ICH E6 GCP, FDA CFR, and applicable global regulations.
- Experience supporting/leading regulatory inspections (FDA, EMA, MHRA, or others).
- Experience providing quality oversight of CROs, vendors, laboratories, and outsourced service providers.
- Ability to influence cross-functional teams in a matrix organization.
- Experience with ICH E6(R3) Quality by Design and Quality Risk Management.
- Excellent communication/presentation; ability to brief senior leadership and inspectors.
- Strong critical thinking to synthesize complex, ambiguous information to drive resolution.