Serves as a subject matter expert in Quality Risk Management, partnering with GCP and GVP Quality colleagues and cross-functional development teams to proactively identify, assess, and mitigate quality risks across Denali's clinical development programs. Strengthens quality oversight by driving risk-based decision making, ensuring regulatory compliance, and advancing a culture of continuous improvement. Leads quality risk management processes, metrics, and vendor oversight activities that support inspection readiness and the successful execution of clinical trials. Key Accountabilities / Core Job 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 the detection, investigation, documentation, and resolution of GCP noncompliance. • Maintain quality oversight of the Clinical Trial Risk Tracking Program and ensure risks are appropriately documented, monitored, and escalated. • Analyze quality and compliance data, identify trends, develop meaningful metrics, and communicate insights and recommendations to leadership and cross-functional stakeholders. • Review deviations, noncompliance, and quality events across development programs to identify systemic risks and drive continuous improvement initiatives. • Lead GCP and GVP vendor qualification and ongoing quality oversight activities to ensure compliance with applicable regulatory requirements and company standards. • Support regulatory inspections and audits through inspection readiness activities, documentation review, response development, and follow-up actions. • Contribute to the ongoing enhancement of the Quality Management System (QMS) by improving quality risk management processes, tools, and best practices. Qualifications / Skills • Typically requires a Bachelor's degree with 12+ years of relevant GCP Quality Assurance experience, a Master's degree with 10+ years of relevant experience, or a PhD with 7+ years of relevant experience; or an equivalent combination of education and experience. • Demonstrated expertise in ICH E6 Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), FDA regulations, and other applicable global regulatory requirements. • Experience applying Quality by Design (QbD), Risk-Based Quality Management (RBQM), and Quality Management System (QMS) principles within clinical development. • Experience leading GCP deviation, CAPA, vendor qualification, and quality risk management processes in a GxP-regulated environment. • Strong analytical and critical thinking skills with the ability to evaluate complex quality risks, identify trends, and develop practical, risk-based solutions. • Excellent written, verbal, and interpersonal communication skills with demonstrated ability to influence and collaborate across cross-functional teams without direct authority. • Ability to manage multiple priorities in a dynamic, fast-paced environment while maintaining a high level of quality, accuracy, and attention to detail. 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.