Executive Director & Site Quality Lead
Denali Therapeutics
August 25, 2026
On-site
Salt Lake City, UT
Operations
Key Accountabilities/Core Job Responsibilities
- Oversee GMP/GLP Quality operations in Utah, including QC labs/testing, batch record reviews and release, environmental monitoring, and external testing labs.
- Ensure overall site compliance and inspection readiness for health authority inspections.
- Partner with the Utah site head on site culture, long-term strategy, and inspection readiness.
- Build, supervise, develop, promote, hire, and train the GxP QA/QC team.
- Represent Quality on the Utah Site Leadership Team and Denali Quality Leadership Team.
- Establish and monitor site quality metrics/KPIs for performance monitoring and Quality System Management Reviews.
- Implement/maintain/optimize quality systems (document control, change management, deviations, CAPAs, audits, compliance initiatives).
- Support GMP site qualification (SOPs, work instructions, specifications, stability studies, method validations, test methods, utility/equipment/room qualifications).
- Lead direct reports (goal setting, growth planning, training compliance, feedback).
Qualifications/Skills
- BS in a scientific discipline (MS and quality/compliance/regulatory certification preferred); 15+ years GMP pharmaceutical experience, including 12+ years people leadership.
- Experience with in-house manufacturing, QC testing, and CMC development.
- Large molecule/commercialization experience (plus).
- Inspection management, mock inspections, Health Authority interactions.
- Strong knowledge of 21 CFR 210-211, Part 11, 610 & 820; EU cGMP/GLPs; ICH quality/guidelines.
- Familiarity with eQMS systems.
- Domestic and international travel.
Benefits
- Competitive total rewards package including 401k, healthcare coverage, and ESPP.
Application
- Learn more at https://www.denalitherapeutics.com/careers
- Oversee GMP/GLP Quality operations in Utah, including QC labs/testing, batch record reviews and release, environmental monitoring, and external testing labs.
- Ensure overall site compliance and inspection readiness for health authority inspections.
- Partner with the Utah site head on site culture, long-term strategy, and inspection readiness.
- Build, supervise, develop, promote, hire, and train the GxP QA/QC team.
- Represent Quality on the Utah Site Leadership Team and Denali Quality Leadership Team.
- Establish and monitor site quality metrics/KPIs for performance monitoring and Quality System Management Reviews.
- Implement/maintain/optimize quality systems (document control, change management, deviations, CAPAs, audits, compliance initiatives).
- Support GMP site qualification (SOPs, work instructions, specifications, stability studies, method validations, test methods, utility/equipment/room qualifications).
- Lead direct reports (goal setting, growth planning, training compliance, feedback).
Qualifications/Skills
- BS in a scientific discipline (MS and quality/compliance/regulatory certification preferred); 15+ years GMP pharmaceutical experience, including 12+ years people leadership.
- Experience with in-house manufacturing, QC testing, and CMC development.
- Large molecule/commercialization experience (plus).
- Inspection management, mock inspections, Health Authority interactions.
- Strong knowledge of 21 CFR 210-211, Part 11, 610 & 820; EU cGMP/GLPs; ICH quality/guidelines.
- Familiarity with eQMS systems.
- Domestic and international travel.
Benefits
- Competitive total rewards package including 401k, healthcare coverage, and ESPP.
Application
- Learn more at https://www.denalitherapeutics.com/careers