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About the Role

Denali Therapeutics is seeking a Quality Risk Management subject matter expert to partner with GCP and GVP Quality colleagues and cross-functional development teams. This role will proactively identify, assess, and mitigate quality risks across clinical development programs, strengthen quality oversight through risk-based decision making, ensure regulatory compliance, and advance a culture of continuous improvement. The position leads quality risk management processes, metrics, and vendor oversight activities to support inspection readiness and successful clinical trial execution.

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.

Requirements

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.

Skills

Quality Risk Management
GCP
GVP
Quality by Design (QbD)
Risk-Based Quality Management (RBQM)
Quality Management System (QMS)
ICH E6 Good Clinical Practice
FDA regulations
Analytical skills
Critical thinking
Communication skills
Collaboration

Experience Level

12+ years of relevant GCP Quality Assurance experience (with Bachelor's)
10+ years of relevant experience (with Master's)
7+ years of relevant experience (with PhD)

Education Level

Bachelor's degree
Master's degree
PhD

Salary/Compensations

$171,000.00 to $223,000.00

Benefits

401k
Healthcare coverage
ESPP

About the Company

Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.
Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.

Equal Opportunity

Denali is committed to its core company value of unity by creating a diverse and inclusive environment.
We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.