Executive Director & Site Quality Lead

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.