Denali Therapeutics brings the power of biotherapeutics to the whole body, including the brain. We discover, develop and deliver medicines for people living with serious diseases. Backed by GV.
About the role
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.
What they're looking for
- 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
More about this role
Neurodegenerative diseases are one of the largest medical challenges of our time. 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.
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...
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