Senior Director Site Quality & Compliance (GMP/GLP)

Denali Therapeutics; Salt Lake City (UT); On-site; USD 260,000 - 360,000; Full time

Job summary

Denali Therapeutics in Salt Lake City is seeking an Executive Director & Site Quality Lead to shape and lead QA/QC at our Utah site, ensuring GMP/GLP compliance and inspection readiness for potential commercial launch. Reporting to the VP of Quality, you will build teams, drive Quality System improvements, and partner with site leadership.

The role requires a BS in science, 15+ years GMP experience, and strong leadership; travel domestically and internationally may be required.

Qualifications

• BS in science; 15+ years GMP in pharma; 12+ years of leadership
• Experience with in-house manufacturing, QC testing, and CMC
• Knowledge of 21 CFR 210-211, Part 11, 820 cGMP/GLPs; EU cGMP/GLPs; ICH guidelines
• Travel domestically and internationally

Responsibilities

• Oversee GMP/GLP QA/QC operations in Utah
• Ensure site is inspection-ready for health authority inspections
• Build, supervise and develop GxP QA/QC teams
• Represent Quality on the Utah Site Leadership Team and Denali Quality Leadership Team
• Establish and monitor site quality metrics and KPIs
• Lead audits, CAPAs, deviations, change management and compliance initiatives

Skills

GMP/GLP Quality Ops

People Leadership

Inspection Readiness

Quality Systems

Regulatory Knowledge

Education

BS in Science/Related Field

MS or QA Certification (preferred)

Tools

eQMS

Job description

Denali Therapeutics in Salt Lake City is seeking an Executive Director & Site Quality Lead to shape and lead QA/QC at our Utah site, ensuring GMP/GLP compliance and inspection readiness for potential commercial launch. Reporting to the VP of Quality, you will build teams, drive Quality System improvements, and partner with site leadership.

The role requires a BS in science, 15+ years GMP experience, and strong leadership; travel domestically and internationally may be required.