This role delivers strategic GCP quality oversight across Denali's clinical trial portfolio, anchoring inspection readiness, risk-based quality decision-making, and continuous improvement of the GCP Quality Management System. Providing strategic leadership in quality risk management, inspection readiness, Sponsor oversight, and continuous improvement across the clinical development lifecycle. It sets the standard for compliance and ethical conduct across study teams, site leadership, and external partners, translating regulatory expectations into practical, scalable quality processes. The role shapes how Denali's quality systems evolve as the clinical portfolio grows, exercising independent judgment on complex, ambiguous compliance matters with limited precedent. Key Accountabilities/Core Job Responsibilities: - Lead GCP quality strategy on assigned Study Execution Teams (SETs), establishing a cohesive framework across Denali's clinical trials. - 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 strategies throughout study execution. - Own risk-based monitoring and analysis of quality issues, delivering strategic guidance aligned with ICH-GCP and applicable global regulations. - Lead Sponsor inspection strategy, inspection management, regulatory interactions, inspection response activities, and CAPA effectiveness. - Identify quality and compliance gaps, direct root cause analysis, and drive CAPA development to resolution.Oversee CAPA implementation, effectiveness reviews, and continuous improvement activities. - Lead evaluation, selection, and ongoing quality oversight of CROs and clinical vendors. - Design and continuously improve GCP Quality Systems, SOPs, and the broader Quality Management System. - Lead development of inspection strategy documents, study storyboards, and inspection readiness tools. - Own QA review of essential clinical trial documents and lead implementation of internal GCP QA processes and tools. - Represent Clinical Quality Assurance in cross-functional initiatives, championing a culture of compliance, ethics, and patient safety across clinical programs. Qualifications/Skills: - Typically requires 12+ years of related experience with a Bachelor's degree; or relevant combination of degree and experience - Experience developing, implementing, or improving Quality Management Systems. - Working knowledge of ICH E6 GCP guidelines, FDA Code of Federal Regulations, and other applicable global regulations. - Demonstrated experience supporting or leading regulatory inspections (FDA, EMA, MHRA or other global regulatory authorities) - Demonstrated experience providing quality oversight of CROs, vendors, laboratories, and other outsourced clinical service providers. - Demonstrated ability to influence cross-functional teams and lead strategic quality initiatives in a matrix organization. - Experience implementing ICH E6(R3) Quality by Design and Quality Risk Management principles. - Excellent communication and presentation skills with demonstrated ability to communicate complex quality issues to senior leadership and regulatory inspectors. - Strong critical-thinking skills, with the ability to synthesize complex, ambiguous information from multiple sources to drive resolution. Salary Range: $171,000.00 to $223,000.00 . Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.