GCP Quality Strategy & Inspection Readiness Lead

Denali Therapeutics; United States; Remote; USD 171,000 - 223,000; Full time

Benefits offered by this job

401k

Healthcare coverage

ESPP

Job summary

Denali Therapeutics seeks a senior quality professional to provide strategic GCP quality oversight across the clinical trial portfolio, anchoring inspection readiness, risk-based decision-making, and continuous improvement of the GCP Quality Management System.

You will lead CRO oversight, develop inspection strategies, and translate regulatory expectations into scalable quality processes that guide clinical development with independence and judgment.

Qualifications

• Typically requires 12+ years of related experience with a Bachelor’s degree.
• Experience developing or improving Quality Management Systems.
• Working knowledge of ICH E6 GCP guidelines and FDA regulations.
• Experience supporting regulatory inspections (FDA/EMA/MHRA).
• Ability to influence cross-functional teams and lead strategic quality initiatives.

Responsibilities

• Lead GCP quality strategy on Study Execution Teams and cross-functional efforts.
• Partner with site leaders to drive site-level quality maturity and operations.
• Lead proactive quality risk assessments and mitigation across studies.
• Own risk-based monitoring and analysis of quality issues per ICH-GCP.
• Lead Sponsor inspection strategy and regulatory interactions, CAPA oversight.
• Identify gaps, perform root cause analysis, and drive CAPA implementation.
• Oversee CRO/vendor quality oversight and selection.
• Design and improve GCP Quality Systems, SOPs, and QA tools.
• Develop inspection strategy documents and readiness tools.
• Provide QA review of essential trial documents and internal QA processes.

Skills

Quality Management Systems

ICH E6 GCP

Regulatory Inspections

Cross-functional Leadership

Quality by Design

Quality Risk Management

Strategic Quality Initiatives

Communication Skills

Education

Bachelor’s degree

Job description

Denali Therapeutics seeks a senior quality professional to provide strategic GCP quality oversight across the clinical trial portfolio, anchoring inspection readiness, risk-based decision-making, and continuous improvement of the GCP Quality Management System.

You will lead CRO oversight, develop inspection strategies, and translate regulatory expectations into scalable quality processes that guide clinical development with independence and judgment.