Senior GCP Quality & Risk Leader

Denali Therapeutics Inc; South San Francisco (CA); On-site; USD 171,000 - 223,000; Full time

Benefits offered by this job

401k

Healthcare coverage

ESPP

Broad range of other benefits

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

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

Education

Bachelor's degree + 12+ years GCP QA

Master's degree + 10+ years GCP QA

PhD + 7+ years GCP QA

Tools

QMS software

Regulatory databases

Job description

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.