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Job description
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.
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Worksite address
salt lake city, UT, 84193, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.