Associate Director, Risk Management

Denali Therapeutics Inc; South San Francisco (CA); Vor Ort; USD 171.000 - 223.000; Vollzeit

Benefits dieser Stelle

401k

Healthcare coverage

ESPP

Broad range of other benefits

Zusammenfassung

Denali Therapeutics Inc is seeking an accomplished GCP Quality Assurance leader to oversee deviation, CAPA, and risk management across clinical development programs. You will partner with study teams, provide expert guidance on GCP/GVP compliance, and ensure ongoing quality oversight of risk tracking and QA processes.

With a strong background in ICH E6, QbD, RBQM and QMS, you will drive inspection readiness, support regulatory audits, and contribute to continuous improvement.

Qualifikationen

• Bachelor's degree with 12+ years of GCP QA experience, or an equivalent combination.
• Master's degree with 10+ years, or a PhD with 7+ years in GCP QA.
• Experience in ICH E6 GCP, GVP, FDA regulations and global regulatory requirements.
• Experience applying QbD, RBQM, and QMS in clinical development.
• Experience leading GCP deviation, CAPA, vendor qualification and risk mgmt in GxP.

Aufgaben

• Lead GCP deviation and CAPA processes with investigations, implementation and closure.
• Partner with study teams to identify, assess, and mitigate quality risks across programs.
• Serve as SME on GCP quality risk management and regulatory guidance.
• Maintain QA oversight of the Clinical Trial Risk Tracking Program and escalation.
• Analyze quality data, identify trends, and communicate insights to leadership.
• Review deviations and quality events to drive continuous improvement.
• Lead GCP and GVP vendor qualification and ongoing quality oversight.
• Support regulatory inspections and audits through readiness and response.
• Contribute to ongoing enhancement of the QMS and risk processes.

Kenntnisse

GCP Quality Assurance

GxP compliance

Quality by Design (QbD)

RBQM

Quality Management System (QMS)

Regulatory knowledge

Cross-functional collaboration

Analytical thinking

Communication skills

Vendor qualification

Ausbildung

Bachelor's degree + 12+ years GCP QA

Master's degree + 10+ years GCP QA

PhD + 7+ years GCP QA

Tools

QMS software

Regulatory databases

Jobbeschreibung

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.

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.

• 401k
• healthcare coverage
• ESPP
• a broad range of other benefits

Learn more at https://www.denalitherapeutics.com/careers

Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits.

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.

“Life at Denali” is a living reflection of our values: trust, unity, grit and growth. These are not just words we share—they shape how we show up, collaborate and push boundaries together. From the lab to the community, across functions and milestones, our culture thrives on shared purpose and relentless pursuit.